ClinicalTrials.gg
CompletedNCT03508726Updated Jun 18, 2026Results posted

High Dose Ascorbate With Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas

A Phase 1/2 interventional study of Ascorbate in Soft Tissue Sarcoma, sponsored by Mohammed Milhem. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by Mohammed Milhem · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a single-arm open-label phase Ib/II clinical study assessing the efficacy of concurrent high dose ascorbate in combination with radiotherapy in patients with locally advanced, resectable, high grade sarcomas.

Read the detailed description

Phase Ib:

The phase Ib portion of this study is to ensure the safety and tolerability of high dose ascorbate in combination with external beam radiation therapy (EBRT) as assessed by incidence of dose-limiting toxicities (DLT). EBRT will be given at the standard dose for resectable soft tissue sarcomas according to the NCCN sarcoma guidelines.2 Patients will receive 50 Gy over 5 weeks, during which time they will be receiving three times a week IV high dose ascorbate. IV ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation to allow for adequate tissue healing and resolution of acute toxicities.

Phase 2:

The phase 2 part of the study will provide an estimate of the relative treatment effect of pharmacological ascorbate in combination with preoperative EBRT in subjects with locally advanced, resectable, extremity, trunk or retroperitoneal high grade sarcomas, as measured by pathological response rates.

As above, patients will receive the first dose of pharmacological ascorbate intravenously on day 1 of week 1 provided no reactions are seen to the test dose. This will be followed by 3 times a week dosing at Dose 0 until completion of EBRT. Standard doses of radiation for resectable soft tissue sarcomas according to the NCCN sarcoma guidelines will be administered.2 Patients will receive preoperative radiation at a dose of 50 Gy over 5 weeks starting on week 1 day 1. Subjects will be followed either by clinic visit or phone contact every 12 weeks for approximately 24 months after the end of the treatment phase, at which time the initial survival data and disease recurrence will be assessed.

02

Conditions studied

  • Soft Tissue Sarcoma

Browse trials for

Keywords

  • Sarcoma
  • Soft tissue
03

In context

Sarcoma

1,607 studies on the registry are indexed under Sarcoma; 366 are open to participants now.

This study's enrollment of 25 is below the median of 40 across 1,255 interventional studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

Mohammed Milhem is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject or subject's legally acceptable representative has provided .
  2. confirmed diagnosis of locally advanced soft tissue sarcoma of extremity, trunk or retroperitoneum that is unresectable with clear wide margins, for which preoperative radiotherapy is considered appropriate

    - Including (stage IV) disease for which radiotherapy and surgical resection of the primary tumor are indicated.

  3. Patients with locally recurrent sarcoma after surgery alone are eligible for enrollment if other inclusion criteria are met.
  4. Patients do not have histologic subtypes: GIST, Desmoid, Ewing sarcoma, bone sarcomas and Kaposi sarcoma.
  5. Age ≥18 years.
  6. Patients with a history of non-melanomatous skin cancer, in situ carcinoma, or low-risk prostate cancer can be enrolled.
  7. performance status \</=1.
  8. Tolerate one test dose (15g) of ascorbate.
  9. Patient must have :

    • Tumor size at least >/= 5 cm in the longest diameter as measured by CT scan or MRI for which radiation is feasible and indicated.

Exclusion criteria

Exclusion Criteria:

  1. Inadequate organ function within 21 days of Day 1 of study as defined by:

    • \< 9.0 g/dL
    • (ANC) \</= 1500 per mm3
    • count \</= 100,000 per mm3
    • Total >/= 1.5 × . Subjects with direct bilirubin \< ULN with total bilirubin levels > 1.5 X ULN will not be excluded.
    • (AST) or alanine aminotransferase (ALT) > 2.5 × ULN
    • Alkaline phosphatase > 2.5 × ULN
    • PT (or ) and PTT (or aPTT) >/= 1.5 × ULN
    • Creatinine > 2.0 × ULN
  2. G6PD (glucose-6-phosphate dehydrogenase) deficiency.
  3. Prior history of symptomatic oxalate kidney stones within the last year.
  4. Prior radiation therapy in excess of 20 Gy to the site of the current diagnosis of sarcoma. No overlap with prior radiation fields in excess of 20 Gy is allowed.
  5. Prior history of receiving pharmacological ascorbate.
  6. Patients actively receiving insulin therapy and needing daily fingerstick for glucose monitoring.
  7. Concurrent, , active within two years of study enrollment.
  8. Female subjects who are pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of study treatment.
  9. Female subjects of or male subjects who are unwilling to use 2 highly effective methods of during study treatment and through 3 months after the last dose of study treatment.
  10. Currently receiving treatment in another invasive device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
  11. Patients who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide. High dose ascorbic acid may affect urine acidification and, as a result, may affect clearance rates of these drugs.
  12. Known CNS disease, except for treated : Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain performed within 3 months prior to Day 1 will be excluded.
  13. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ascorbate.
  14. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  15. Known -positive and \& C individuals. High-dose ascorbate acid is a known CYP450 3A4 inducer, which results in lower serum levels of antiretroviral drugs.
  16. Patients who are on warfarin and cannot have a drug substitution or who decline the drug substitution.
Terms in these criteria, in plain language(21)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Phase I dose escalation cohort

    Participants will receive radiation therapy over 5 weeks, during which time they will be receiving ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.

    Drug: Ascorbate

  • Experimental
    Phase II Cohort

    Participants will receive radiation therapy over 5 weeks, during which time they will be receiving intravenous (IV) ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.

    Drug: Ascorbate

Interventions

  • Phase 1 dose escalation: 75gm IV three times a week Phase II portion: 75gm IV three times a week if no dose limiting toxicities are experienced in the Phase I portion. Otherwise, ascorbate dose will be deescalated to 62.5 gm IV

    Also known as: Ascorbic Acid, Vitamin C, Pharmacological ascorbate

06

What researchers measure

Primary outcomes

  1. Number of Participants That Experienced Dose Limiting Toxicities (DLTs) Using CTCAE, Version 4.0

    To examine the toxicity related to the therapy by measuring the number attributed adverse event (definite, probable or possible) according to CTCAE version 4.0.

    Time frame: Start of treatment up to 4 weeks after the last ascorbate infusion

  2. Number of Participants With Pathologic Tumor Necrosis ≥ 95% Following Concurrent Radiation Therapy and Ascorbate

    To estimate the efficacy of neoadjuvant ascorbate and radiotherapy as assessed by the pathological complete response rates (pCR) in subjects with locally advanced high grade soft tissue sarcomas.

    Time frame: Start of treatment up to 6 weeks after the last ascorbate infusion

Secondary outcomes

  1. Event-Free Survival at 2 Years

    Event-free survival is defined as the time from treatment initiation until progression which precludes surgery, recurrence or death due to any cause. Otherwise, patients are censored at last disease assessment.

    Time frame: Enrollment or start of treatment up to 2 years following end of treatment

  2. Overall Response Rate

    Overall response rate (ORR) is the percentage of patients with a complete or partial response preoperatively as measured by RECIST 1.1 or a later tool for monitoring disease progression.

    Time frame: Enrollment or start of treatment up to 2 years following end of treatment

  3. Overall Survival at 2 Years

    Overall survival is defined as the time from treatment initiation to death due to any cause. Patients still alive are censored at last date known to be alive.

    Time frame: Enrollment or start of treatment up to 2 years following end of treatment

  4. Skin Toxicity

    Pathologist to grade radiation related skin toxicity.

    Time frame: Within two years following end of treatment

  5. Labile Iron

    To measure labile iron using T2\* imaging sequence on MRI pre and post ascorbate treatments and compare with serum iron measurements

    Time frame: Within two years following end of treatment

  6. Evaluate Diffusion Weighted Imaging Sequences

    To evaluate diffusion weighted imaging sequences on MRI in pre and post treatment tumors and correlate it with necrosis and survival

    Time frame: Within two years following end of treatment

07

Results

Posted Jun 6, 2023

Participant flow

Participants were recruited from the Principal Investigator's and Sub-Investigator's clinics at Holden Comprehensive Cancer Center.

Participant flow — Overall Study
MilestonePhase I: Ascorbate 75 mg IV InfusionPhase II: Ascorbate 75 mg IV Infusion
Started619
Completed618
Not completed01
Withdrew: Withdrawal by subject01

Outcome measures

PrimaryNumber of Participants That Experienced Dose Limiting Toxicities (DLTs) Using CTCAE, Version 4.0

To examine the toxicity related to the therapy by measuring the number attributed adverse event (definite, probable or possible) according to CTCAE version 4.0.

Time frame:
Start of treatment up to 4 weeks after the last ascorbate infusion
Reported as:
Number · participants
Number of Participants That Experienced Dose Limiting Toxicities (DLTs) Using CTCAE, Version 4.0
participantsPhase I: Ascorbate 75 mg IV Infusion
Number of Participants That Experienced Dose Limiting Toxicities (DLTs) Using CTCAE, Version 4.00
PrimaryNumber of Participants With Pathologic Tumor Necrosis ≥ 95% Following Concurrent Radiation Therapy and Ascorbate

To estimate the efficacy of neoadjuvant ascorbate and radiotherapy as assessed by the pathological complete response rates (pCR) in subjects with locally advanced high grade soft tissue sarcomas.

Time frame:
Start of treatment up to 6 weeks after the last ascorbate infusion
Reported as:
Count of participants · Participants
Number of Participants With Pathologic Tumor Necrosis ≥ 95% Following Concurrent Radiation Therapy and Ascorbate
ParticipantsPhase I: Ascorbate 75 mg IV InfusionPhase II: Ascorbate 75 mg IV Infusion
Number of Participants With Pathologic Tumor Necrosis ≥ 95% Following Concurrent Radiation Therapy and Ascorbate21
SecondaryEvent-Free Survival at 2 Years

Event-free survival is defined as the time from treatment initiation until progression which precludes surgery, recurrence or death due to any cause. Otherwise, patients are censored at last disease assessment.

Time frame:
Enrollment or start of treatment up to 2 years following end of treatment
Reported as:
Number · Cumulative Probability
Event-Free Survival at 2 Years
Cumulative ProbabilityPhase I: Ascorbate 75 mg IV InfusionPhase II: Ascorbate 75 mg IV Infusion
Event-Free Survival at 2 Years100 (100 to 100)46 (23 to 67)
SecondaryOverall Response Rate

Overall response rate (ORR) is the percentage of patients with a complete or partial response preoperatively as measured by RECIST 1.1 or a later tool for monitoring disease progression.

Time frame:
Enrollment or start of treatment up to 2 years following end of treatment
Reported as:
Count of participants · Participants
Overall Response Rate
ParticipantsPhase I: Ascorbate 75 mg IV InfusionPhase II: Ascorbate 75 mg IV Infusion
Overall Response Rate02
SecondaryOverall Survival at 2 Years

Overall survival is defined as the time from treatment initiation to death due to any cause. Patients still alive are censored at last date known to be alive.

Time frame:
Enrollment or start of treatment up to 2 years following end of treatment
Reported as:
Number · Cumulative Probability
Overall Survival at 2 Years
Cumulative ProbabilityPhase I: Ascorbate 75 mg IV InfusionPhase II: Ascorbate 75 mg IV Infusion
Overall Survival at 2 Years100 (100 to 100)74 (48 to 88)
SecondarySkin Toxicity

Pathologist to grade radiation related skin toxicity.

Time frame:
Within two years following end of treatment
Reported as:
Number · participants
Skin Toxicity
participantsPhase I: Ascorbate 75 mg IV InfusionPhase II: Ascorbate 75 mg IV Infusion
Grade 049
Grade 112
Grade 216
Grade 302
SecondaryLabile Iron

To measure labile iron using T2\* imaging sequence on MRI pre and post ascorbate treatments and compare with serum iron measurements

Time frame:
Within two years following end of treatment
Reported as:
Count of participants · Participants
Labile Iron
ParticipantsPhase I: Ascorbate 75 mg IV InfusionPhase II: Ascorbate 75 mg IV Infusion
Labile Iron00
SecondaryEvaluate Diffusion Weighted Imaging Sequences

To evaluate diffusion weighted imaging sequences on MRI in pre and post treatment tumors and correlate it with necrosis and survival

Time frame:
Within two years following end of treatment
Reported as:
Count of participants · Participants
Evaluate Diffusion Weighted Imaging Sequences
ParticipantsPhase I: Ascorbate 75 mg IV InfusionPhase II: Ascorbate 75 mg IV Infusion
Evaluate Diffusion Weighted Imaging Sequences00

Adverse events

Collected over Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase I: Ascorbate 75 mg IV Infusion0/6 (0%)0/6 (0%)6/6 (100%)
Phase II: Ascorbate 75 mg IV Infusion5/19 (26.3%)4/19 (21.1%)18/19 (94.7%)
Most frequent serious events
Most frequent serious events
EventPhase I: Ascorbate 75 mg IV InfusionPhase II: Ascorbate 75 mg IV Infusion
Abdominal painGastrointestinal disorders0/61/19
Jejunal obstructionGastrointestinal disorders0/61/19
FeverGeneral disorders and administration site conditions0/61/19
BacteremiaInfections and infestations0/61/19
Kidney infectionInfections and infestations0/61/19
DehydrationMetabolism and nutrition disorders0/61/19
Metabolism and nutrition disorders - Other, specifyMetabolism and nutrition disorders0/61/19
Generalized muscle weaknessMusculoskeletal and connective tissue disorders0/61/19
Tumor painNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/61/19
Most frequent other events
Showing 10 of 78
Most frequent other events
EventPhase I: Ascorbate 75 mg IV InfusionPhase II: Ascorbate 75 mg IV Infusion
NauseaGastrointestinal disorders4/69/19
Lymphocyte count decreasedInvestigations4/67/19
FatigueGeneral disorders and administration site conditions3/65/19
Investigations - Other, specifyInvestigations3/68/19
HypertensionVascular disorders3/62/19
AnemiaBlood and lymphatic system disorders2/67/19
Dry mouthGastrointestinal disorders2/62/19
Dermatitis radiationInjury, poisoning and procedural complications2/63/19
Alanine aminotransferase increasedInvestigations2/62/19
Neutrophil count decreasedInvestigations2/61/19

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Phase I: Ascorbate 75 mg IV InfusionPhase II: Ascorbate 75 mg IV InfusionTotal
<=18 years000
Between 18 and 65 years459
>=65 years21416
Age, Continuous
Age, Continuous(years)Phase I: Ascorbate 75 mg IV InfusionPhase II: Ascorbate 75 mg IV InfusionTotal
Mean60 (39 to 85)67 (42 to 87)65 (39 to 87)
Sex: Female, Male
Sex: Female, Male(Participants)Phase I: Ascorbate 75 mg IV InfusionPhase II: Ascorbate 75 mg IV InfusionTotal
Female4711
Male21214
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Phase I: Ascorbate 75 mg IV InfusionPhase II: Ascorbate 75 mg IV InfusionTotal
Hispanic or Latino000
Not Hispanic or Latino61925
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Phase I: Ascorbate 75 mg IV InfusionPhase II: Ascorbate 75 mg IV InfusionTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American101
White51924
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Phase I: Ascorbate 75 mg IV InfusionPhase II: Ascorbate 75 mg IV InfusionTotal
United States61925
08

Study locations

1 site
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03508726
Lead sponsor
Mohammed Milhem
Collaborators
University of Iowa
Responsible party
Mohammed Milhem (Clinical Professor, University of Iowa) — Sponsor-investigator
First posted
Apr 26, 2018
Start date
Jun 27, 2019
Primary completion
Jun 3, 2022
Completion
Jun 2, 2024
Results posted
Jun 6, 2023
Last update
Jun 18, 2026

Study contacts

Mohammed Milhem, MBBS
principal investigator · University of Iowa

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Ascorbic Acid

Start the discussion