A Phase 1/2 interventional study of Cholecalciferol and Omega 3 fatty acid in Diabetes Mellitus, Type 1, Hypoglycemia and Diabetes Mellitus, sponsored by Rodolfo Alejandro. Completed at 1 site in United States. Open to participants aged 6 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Rodolfo Alejandro · Phase 1/2, Interventional, and Treatment
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Among 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States — 191 open to participants now, 259 under way, 17 of them phase 3. Diabetes Mellitus, Type 1 · United States.
Among the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States, this one is the 766th largest by enrollment of the 1,242 interventional ones that give a count, is one of 74 that started in 2018, is one of 59 in phase 1/2, and was the 828th registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
Browse Diabetes Mellitus, Type 1 studies →191 of the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States are open now. Recruiting first, the newest first:
Emory University · Sites in United States
Ages 31–75 · Healthy volunteers
University of California, Los Angeles · Sites in United States
Ages 18+
Wayne State University · Sites in United States
Ages 16–20
Medtronic MiniMed, Inc. · Sites in United States
Ages 2–80
University of Colorado, Denver · Sites in United States
Ages 10–20
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 412 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 258 (63%) stop at 75 or younger; 185 take children under 18; 64 take healthy volunteers.
This study: 6 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,458 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 206 · Phase 2 267 · Phase 3 167 · Phase 4 74
First in 1983; this study’s year is marked. 74 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 27 is below the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Median enrollment 40 across the 1,242 interventional studies, 64 across the 203 observational. Of the 1,117 that completed or were terminated, 563 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
398 of 1,458 have an industry lead sponsor. The 10 most frequent:
Rodolfo Alejandro is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Rodolfo Alejandro has 9 studies filed under Diabetes Mellitus, Type 1 — fewer than ten, so there is no comparison to draw.
117 of the studies in Diabetes Mellitus, Type 1 with a site in United States that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06914895Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06962280Phase 3Eli Lilly and CompanyA Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT07076199Phase 3Novo Nordisk A/SA Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes | 2027-01-25 |
| NCT06334133Phase 3vTv TherapeuticsCadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes | 2027-04 |
| NCT07056699Phase 3The University of Texas Health Science Center at San AntonioSGLT2i, Pioglitazone, and Ketone Production in T1D | 2027-06-01 |
Add all 117 to your calendar (.ics) → With an account.
Among the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The investigator propose to test the safety and efficacy of a regimen that combines Omega-3 Fatty Acids and Vitamin D in a design that considers timing and duration of administration in relation to their effects and predicted synergies.
These agents may afford promote sustained immune regulation, reduce inflammation, and provide support for the residual beta cell mass. This integrated therapeutic regimen addresses major pathogenic mechanisms in T1D (Type 1 Diabetes) and thus represents a rational and well supported approach to preserve insulin secretion in T1D (Type 1 Diabetes). This approach could halt the disease progress, preserve β-cell function and hopefully reduce dose of insulin required to manage T1D (Type 1 Diabetes). The investigator hypothesizes that Omega-3 Fatty Acids and Vitamin D, administered to patients with newly or established T1D (Type 1 Diabetes) and residual stimulated C-peptide secretion will be safe and may preserve insulin secretion.
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.
Patients must meet all of the following criteria to be eligible to participate in this study:
Exclusion Criteria:
Patients must not meet any of the following criteria to be eligible to participate:
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.
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.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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).
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.
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 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.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The treatment arm A includes Omega-3 Fatty Acids and Cholecalciferol (Vitamin D) supplement.
Drug: Cholecalciferol · Drug: Omega 3 fatty acid
The treatment arm B (control group) will receive only Cholecalciferol (Vitamin D) supplement.
Drug: Cholecalciferol
Oral Administration
Also known as: Vitamin D
Oral Administration
Also known as: Omega 3
Change in MMTT (Mixed Meal Tolerance Test) 90 Min C-peptide
Stimulated (90-minute sample of a MMTT) C-peptide at the 1-year visit greater or equal to baseline level measured by ng/mL. Change in 90-minute C-peptide between baseline and 1-year visit
Time frame: Baseline and 1-Year Visit
Change in Hemoglobin A1c Level
Change in HbA1c between baseline and 1-year
Time frame: Baseline and 1-Year Visit
Change in Insulin Requirements
Difference in insulin requirement at the 1-year visit compared to baseline measured in units/kg/day
Time frame: Baseline and 1-Year Visit
Number of Adverse Events (AE)
Number of adverse events (AE) comparable to general diabetes population
Time frame: Through study completion, and average of one year
| Milestone | Omega-3 and Vitamin D Combination | Vitamin D Only |
|---|---|---|
| Started | 12 | 15 |
| Completed | 7 | 8 |
| Not completed | 5 | 7 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Withdrawal by subject | 4 | 4 |
| Withdrew: Physician decision | 0 | 1 |
Stimulated (90-minute sample of a MMTT) C-peptide at the 1-year visit greater or equal to baseline level measured by ng/mL. Change in 90-minute C-peptide between baseline and 1-year visit
| ng/mL | Omega-3 and Vitamin D Combination | Vitamin D Only |
|---|---|---|
| Change in MMTT (Mixed Meal Tolerance Test) 90 Min C-peptide | -1.23 (-1.60 to -0.17) | -0.62 (-1.44 to -0.15) |
Change in HbA1c between baseline and 1-year
| percentage of HbA1c | Omega-3 and Vitamin D Combination | Vitamin D Only |
|---|---|---|
| Change in Hemoglobin A1c Level | 0.00 (-0.30 to 2.50) | -0.55 (-3.10 to 0.30) |
Difference in insulin requirement at the 1-year visit compared to baseline measured in units/kg/day
| units/kg/day | Omega-3 and Vitamin D Combination | Vitamin D Only |
|---|---|---|
| Change in Insulin Requirements | 0.16 (0.02 to 0.52) | 0.15 (-0.20 to 0.87) |
Number of adverse events (AE) comparable to general diabetes population
| number of adverse events | Omega-3 and Vitamin D Combination | Vitamin D Only |
|---|---|---|
| Number of Adverse Events (AE) | 31 | 28 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omega-3 and Vitamin D Combination | 0/12 (0%) | 0/12 (0%) | 8/12 (66.7%) |
| Vitamin D Only | 0/15 (0%) | 2/15 (13.3%) | 8/15 (53.3%) |
| Event | Omega-3 and Vitamin D Combination | Vitamin D Only |
|---|---|---|
| Acute perforated apendicitisGastrointestinal disorders | 0/12 | 1/15 |
| Diabetes KetoacidosisEndocrine disorders | 0/12 | 1/15 |
| Event | Omega-3 and Vitamin D Combination | Vitamin D Only |
|---|---|---|
| HypoglycemiaEndocrine disorders | 3/12 | 3/15 |
| COVID-19 InfectionInfections and infestations | 0/12 | 3/15 |
| Influenza ARespiratory, thoracic and mediastinal disorders | 2/12 | 0/15 |
| HyperkalemiaGeneral disorders | 1/12 | 0/15 |
| HyperphosphatemiaGeneral disorders | 1/12 | 0/15 |
| Fecal incontinenceGastrointestinal disorders | 1/12 | 0/15 |
| Oily rectal dischargeGastrointestinal disorders | 1/12 | 0/15 |
| GastroenteritisGastrointestinal disorders | 1/12 | 0/15 |
| NeutropeniaBlood and lymphatic system disorders | 1/12 | 0/15 |
| Celiac DiseaseGastrointestinal disorders | 1/12 | 0/15 |
| Age, Categorical(Participants) | Omega-3 and Vitamin D Combination | Vitamin D Only | Total |
|---|---|---|---|
| <=18 years | 10 | 12 | 22 |
| Between 18 and 65 years | 2 | 3 | 5 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Omega-3 and Vitamin D Combination | Vitamin D Only | Total |
|---|---|---|---|
| Female | 4 | 7 | 11 |
| Male | 8 | 8 | 16 |
| Race/Ethnicity, Customized(Participants) | Omega-3 and Vitamin D Combination | Vitamin D Only | Total |
|---|---|---|---|
| White, Non-Hispanic | 6 | 7 | 13 |
| White, Hispanic | 5 | 7 | 12 |
| Asian | 1 | 1 | 2 |
| Region of Enrollment(participants) | Omega-3 and Vitamin D Combination | Vitamin D Only | Total |
|---|---|---|---|
| United States | 12 | 15 | 27 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2018 to primary completion in Jul 2024, 72 months.
Results were first posted in Sep 2025, 1 year 1 month after primary completion.
Of 44 phase 1/2 interventional studies under Diabetes Mellitus, Type 1, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 93. This study's 72 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Omega-3 fatty acid
Rodolfo Alejandro