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CompletedNCT03419364Updated Sep 8, 2022Results posted

Study of Nicotinamide in Early Onset Preeclampsia

A Phase 2 interventional study of nicotinamide in Pre-Eclampsia and Pregnancy Related, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-09-08.

Sponsored by University of North Carolina, Chapel Hill · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
23
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study summary

Phase II Study of 2.5 gm of nicotinamide, given daily in 3 divided doses, to measure effect on maternal blood pressure in women with early onset preeclampsia and to determine peak and trough levels of nicotinamide. We will compare peak and trough levels in healthy non-pregnant and healthy pregnant participants.

Read the detailed description

See brief summary above

02

Conditions studied

  • Pre-Eclampsia
  • Pregnancy Related

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03

In context

Pre-Eclampsia

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

This study's enrollment of 23 is below the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.

Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.

Browse University of North Carolina, Chapel Hill studies →

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

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

Diagnosis and Inclusion Criteria

  • Maternal age 18-55 years
  • Singleton pregnancy with no known fetal anomalies

  • Early-onset preeclampsia OR early-onset severe gestational hypertension defined as:

    • Early-onset: between 24 weeks 0 days and -33 weeks 3 days, based on menstrual dating confirmed by first or second trimester ultrasound OR second trimester ultrasound if menstrual dating unavailable;
    • Preeclampsia:
  • New onset hypertension and proteinuria, with systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg on two occasions 6 hours apart and > 300 mg proteinuria on 24 hour urine collection OR urine P/C ratio >0.3;
  • New onset hypertension and NO proteinuria, with systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg on two occasions 6 hours apart and one or more of the following: serum creatinine >1.1 mg/dL or doubling from baseline ,or central nervous system symptoms or visual changes

  • Severe preeclampsia defined as new onset systolic BP > 160 mm Hg and/or diastolic BP > 105 with proteinuria as above or or without proteinuria and one or more of the following criteria listed above

    • Candidate for expectant management for at least 48 hours
    • Deemed clinically stable by primary clinician and candidate for expectant management (delayed delivery) for at least 48 hours;
  • Maternal liver function tests \< 2x
  • Maternal count > 100,000 mm³
  • Planned expectant management
  • Pre-existing medical diseases such as hypertension, diabetes, endocrine disorders, gastrointestinal diseases, are well controlled
  • Fetal well-being established by estimated fetal weight > 5th %tile; normal amniotic fluid volume (MVP > 2 cm); normal Umbilical Artery (UA) Dopplers; or reactive Non Stress Test (NST) or Biophysical Profile (BPP) > 6
  • Delivery not anticipated within 48 hours of enrollment

Exclusion Criteria

  • Pre-existing renal disease (creatinine > 1.5 mg/dL)
  • Any pre-existing medical condition that would increase risk for liver toxicity (e.g. or C; ; Isoniazid (INH) use)
  • Eclampsia; cerebral edema on CT/MRI; headache unrelieved by analgesics
  • Evidence of liver dysfunction (LFTs > 2x ULN)
  • Thrombocytopenia (platelets \< 100,000 mm³)
  • Pulmonary edema
  • HELLP syndrome
  • Evidence of fetal compromise: Estimated Fetal Weight (EFW) \< 5th percentile; or BPP \< 6; or absent or reverse diastolic UA blood flow; or oligohydramnios (MVP \< 2 cm)
  • Placental abruption defined as unexplained vaginal bleeding
  • Preterm labor defined as regular contractions and cervical change
  • Any condition deemed by the investigator to be a risk to mother or fetus in completion of the study
  • Any condition deemed by the investigator to require delivery within 48 hours
Terms in these criteria, in plain language(4)

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.

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.

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.

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.

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.

05

Study design

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

Study arms

  • Experimental
    Nicotinamide - pre-eclampsia

    All participants will receive study agent

    Drug: nicotinamide

  • Experimental
    Nicotinamide - healthy pregnant

    All participants will receive study agent 1000mg in single dose

    Drug: nicotinamide

  • Experimental
    Healthy Non-Pregnant

    All participants will receive study agent 1000mg in single dose

    Drug: nicotinamide

Interventions

  • Drugnicotinamide

    2.5 gm nicotinamide given orally in 3 divided doses: 1000 mg in morning and evening, 500 mg at noon/midday

    Also known as: niacinamide

06

What researchers measure

Primary outcomes

  1. Change in Mean Arterial Blood Pressure (MAP)

    Blood pressure (mmHg) will be used to observe the effect of nicotinamide. The highest MAP (defined as the highest MAP within the 24 hour period prior to the administration of study agent) and the highest MAP through 24 hours after study drug administration.

    Time frame: Baseline, 48 hours

Secondary outcomes

  1. Number of Participants With Alanine Aminotransferase (ALT) =/> 3x Upper Limit of Normal (ULN)

    Time frame: Within 24 hours of any dose, up to a maximum 4 weeks

  2. Number of Participants With Aspartate Aminotransferase (AST) =/> 3x Upper Limit of Normal (ULN)

    Time frame: Within 24 hours of any dose, up to a maximum 4 weeks

  3. Number of Participants With Maternal Side Effects

    Maternal side effects are defined as: facial erythema, hives, sore mouth, dry hair, fatigue, flushing, headache, nausea, and heart burn.

    Time frame: From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks

  4. Percentage of Women Maternal Abdominal Tenderness

    Time frame: From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks

  5. Percentage of Women With Headache Unrelieved by Oral Analgesics

    Time frame: From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks

  6. Percentage of Women With Hematocrit Decrease of More Than 3%

    Time frame: From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks

  7. Percentage of Women With Less Than 500 cc Urine Output in 24 Hours

    Time frame: From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks

  8. Percentage of Fetuses With Category III Non Stress Test Results

    A Non Stress Test is a determination of the current well-being of the fetus, as measured by the fetal heart rate. Category I indicates that the fetus is in a state of well-being and is tolerating the intrauterine environment. Category II indicates a fetal heart rate that is showing some signs of distress. In this instance, obstetric providers will try to improve the intrauterine environment to allow the pregnancy to continue. Category III relates to a fetus whose well-being is compromised - usually requiring rapid intervention, ie expedient delivery.

    Time frame: From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks

  9. Percentage of Fetuses With Biophysical Profile < 6

    Time frame: From initial administration of study agent until 24 hours post last dose

  10. Mean Peak Nicotinamide Level

    The mean was calculated for each group using blood samples drawn on Day 1 at 1 hour post 1000 mg nicotinamide administration routinely given at 8 a.m. Peak nicotinamide level expected at 1 hour post dose.

    Time frame: at 1 hour post 1000 mg nicotinamide administration on Day 1

  11. Mean Trough Concentration Nicotinamide Administration

    The mean was calculated for each group for blood samples drawn on Day 1 8 hours post 1000 mg nicotinamide administration routinely given at 8 a.m. Trough nicotinamide level is measured immediately prior to the next dose.

    Time frame: 8 hours after the 8 a.m. 1000 mg nicotimamide administration on Day 1

07

Results

Posted Sep 8, 2022

Participant flow

Participant flow — Overall Study
MilestoneNicotinamide - Pre-eclampsiaNicotinamide - Healthy PregnantNicotinamide - Healthy Non-Pregnant
Started1166
Signed consent1166
Received intervention966
Completed966
Not completed200
Withdrew: Delivery due to maternal condition200

Outcome measures

PrimaryChange in Mean Arterial Blood Pressure (MAP)

Blood pressure (mmHg) will be used to observe the effect of nicotinamide. The highest MAP (defined as the highest MAP within the 24 hour period prior to the administration of study agent) and the highest MAP through 24 hours after study drug administration.

Time frame:
Baseline, 48 hours
Reported as:
Mean · mmHg
Change in Mean Arterial Blood Pressure (MAP)
mmHgNicotinamide - Pre-eclampsiaNicotinamide - Healthy PregnantNicotinamide - Healthy Non-Pregnant
Change in Mean Arterial Blood Pressure (MAP)0 ± 92 ± 94 ± 6
SecondaryNumber of Participants With Alanine Aminotransferase (ALT) =/> 3x Upper Limit of Normal (ULN)
Time frame:
Within 24 hours of any dose, up to a maximum 4 weeks
Reported as:
Count of participants · Participants
Number of Participants With Alanine Aminotransferase (ALT) =/> 3x Upper Limit of Normal (ULN)
ParticipantsNicotinamide - Pre-eclampsiaNicotinamide - Healthy PregnantNicotinamide - Healthy Non-Pregnant
Number of Participants With Alanine Aminotransferase (ALT) =/> 3x Upper Limit of Normal (ULN)0——
SecondaryNumber of Participants With Aspartate Aminotransferase (AST) =/> 3x Upper Limit of Normal (ULN)
Time frame:
Within 24 hours of any dose, up to a maximum 4 weeks
Reported as:
Count of participants · Participants
Number of Participants With Aspartate Aminotransferase (AST) =/> 3x Upper Limit of Normal (ULN)
ParticipantsNicotinamide - Pre-eclampsiaNicotinamide - Healthy PregnantNicotinamide - Healthy Non-Pregnant
Number of Participants With Aspartate Aminotransferase (AST) =/> 3x Upper Limit of Normal (ULN)0——
SecondaryNumber of Participants With Maternal Side Effects

Maternal side effects are defined as: facial erythema, hives, sore mouth, dry hair, fatigue, flushing, headache, nausea, and heart burn.

Time frame:
From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks
Reported as:
Count of participants · Participants
Number of Participants With Maternal Side Effects
ParticipantsNicotinamide - Pre-eclampsiaNicotinamide - Healthy PregnantNicotinamide - Healthy Non-Pregnant
Number of Participants With Maternal Side Effects000
SecondaryPercentage of Women Maternal Abdominal Tenderness
Time frame:
From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks
Reported as:
Number · percentage of participants
Percentage of Women Maternal Abdominal Tenderness
percentage of participantsNicotinamide - Pre-eclampsiaNicotinamide - Healthy PregnantNicotinamide - Healthy Non-Pregnant
Percentage of Women Maternal Abdominal Tenderness000
SecondaryPercentage of Women With Headache Unrelieved by Oral Analgesics
Time frame:
From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks
Reported as:
Number · percentage of participants
Percentage of Women With Headache Unrelieved by Oral Analgesics
percentage of participantsNicotinamide - Pre-eclampsiaNicotinamide - Healthy PregnantNicotinamide - Healthy Non-Pregnant
Percentage of Women With Headache Unrelieved by Oral Analgesics3300
SecondaryPercentage of Women With Hematocrit Decrease of More Than 3%
Time frame:
From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks
Reported as:
Number · percentage of participants
Percentage of Women With Hematocrit Decrease of More Than 3%
percentage of participantsNicotinamide - Pre-eclampsiaNicotinamide - Healthy PregnantNicotinamide - Healthy Non-Pregnant
Percentage of Women With Hematocrit Decrease of More Than 3%44——
SecondaryPercentage of Women With Less Than 500 cc Urine Output in 24 Hours
Time frame:
From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks
Reported as:
Number · percentage of participants
Percentage of Women With Less Than 500 cc Urine Output in 24 Hours
percentage of participantsNicotinamide - Pre-eclampsiaNicotinamide - Healthy PregnantNicotinamide - Healthy Non-Pregnant
Percentage of Women With Less Than 500 cc Urine Output in 24 Hours0——
SecondaryPercentage of Fetuses With Category III Non Stress Test Results

A Non Stress Test is a determination of the current well-being of the fetus, as measured by the fetal heart rate. Category I indicates that the fetus is in a state of well-being and is tolerating the intrauterine environment. Category II indicates a fetal heart rate that is showing some signs of distress. In this instance, obstetric providers will try to improve the intrauterine environment to allow the pregnancy to continue. Category III relates to a fetus whose well-being is compromised - usually requiring rapid intervention, ie expedient delivery.

Time frame:
From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks
Reported as:
Number · percentage of fetuses
Percentage of Fetuses With Category III Non Stress Test Results
percentage of fetusesNicotinamide - Pre-eclampsiaNicotinamide - Healthy PregnantNicotinamide - Healthy Non-Pregnant
Percentage of Fetuses With Category III Non Stress Test Results0——
SecondaryPercentage of Fetuses With Biophysical Profile < 6
Time frame:
From initial administration of study agent until 24 hours post last dose

No measurements were reported for this outcome.

SecondaryMean Peak Nicotinamide Level

The mean was calculated for each group using blood samples drawn on Day 1 at 1 hour post 1000 mg nicotinamide administration routinely given at 8 a.m. Peak nicotinamide level expected at 1 hour post dose.

Time frame:
at 1 hour post 1000 mg nicotinamide administration on Day 1
Reported as:
Mean · ng/mL
Mean Peak Nicotinamide Level
ng/mLNicotinamide - Pre-eclampsiaNicotinamide - Healthy PregnantNicotinamide - Healthy Non-Pregnant
Mean Peak Nicotinamide Level12701.7 ± 6187.513279.7 ± 970.716314.1 ± 3337.1
SecondaryMean Trough Concentration Nicotinamide Administration

The mean was calculated for each group for blood samples drawn on Day 1 8 hours post 1000 mg nicotinamide administration routinely given at 8 a.m. Trough nicotinamide level is measured immediately prior to the next dose.

Time frame:
8 hours after the 8 a.m. 1000 mg nicotimamide administration on Day 1
Reported as:
Mean · ng/mL
Mean Trough Concentration Nicotinamide Administration
ng/mLNicotinamide - Pre-eclampsiaNicotinamide - Healthy PregnantNicotinamide - Healthy Non-Pregnant
Mean Trough Concentration Nicotinamide Administration479.2 ± 967.31490.7 ± 1907.81991.2 ± 2783.6

Adverse events

Collected over From signing of informed consent up to 30 days after infant delivery, ranging from 31 to 58 days total.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nicotinamide - Pre-eclampsia0/9 (0%)0/9 (0%)0/9 (0%)
Nicotinamide - Healthy Pregnant0/6 (0%)0/6 (0%)0/6 (0%)
Nicotinamide - Healthy Non-Pregnant0/6 (0%)0/6 (0%)0/6 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Nicotinamide - Pre-eclampsiaNicotinamide - Healthy PregnantNicotinamide - Healthy Non-PregnantTotal
<=18 years0000
Between 18 and 65 years96621
>=65 years0000
Sex: Female, Male
Sex: Female, Male(Participants)Nicotinamide - Pre-eclampsiaNicotinamide - Healthy PregnantNicotinamide - Healthy Non-PregnantTotal
Female96621
Male0000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Nicotinamide - Pre-eclampsiaNicotinamide - Healthy PregnantNicotinamide - Healthy Non-PregnantTotal
Hispanic or Latino3025
Not Hispanic or Latino66416
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Nicotinamide - Pre-eclampsiaNicotinamide - Healthy PregnantNicotinamide - Healthy Non-PregnantTotal
American Indian or Alaska Native0000
Asian0022
Native Hawaiian or Other Pacific Islander0000
Black or African American3003
White46414
More than one race0000
Unknown or Not Reported2002
Region of Enrollment
Region of Enrollment(Participants)Nicotinamide - Pre-eclampsiaNicotinamide - Healthy PregnantNicotinamide - Healthy Non-PregnantTotal
United States96621
08

Study locations

1 site
  • UNC at Chapel Hill
    Chapel Hill, North Carolina 27599, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Aug 2021, 45 months.

Results were first posted in Sep 2022, 1 year after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2018
First posted
Feb 1, 2018
StartActual
Nov 1, 2017
Primary completionActual
Aug 31, 2021
CompletionActual
Aug 31, 2021
Results first posted
Sep 8, 2022
Last update
Sep 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03419364
Lead sponsor
University of North Carolina, Chapel Hill
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Feb 1, 2018
Start date
Nov 1, 2017
Primary completion
Aug 31, 2021
Completion
Aug 31, 2021
Results posted
Sep 8, 2022
Last update
Sep 8, 2022

Study contacts

Kim Boggess, MD
principal investigator · UNC_Chapel Hill

Oversight

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

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