Phase I Study of Nicotinamide for Early Onset Preeclampsia

This is a Phase I study of vitamin B3-amide (nicotinamide) dietary supplementation in pregnant women with early onset preeclampsia. The investigators will enroll 10 pregnant women at 24-32 weeks' gestation with the diagnosis of preeclampsia. If the woman is anticipated to remain undelivered for 48 hours after diagnosis she will receive vitamin B3-amide, 500 mg/day given in the morning (n=5) or 1000 mg given in the morning (n=5), continuing until delivery or for 14 days, whichever occurs first. Maternal blood will be collected at baseline and twice a day on days 1, 3, and 7 of nicotinamide administration to measure nicotinamide metabolites, The objectives of this Phase I study are to to test safety of nicotinamide.

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Key information

Conditions

Pregnancy Induced Hypertension Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Superimposed Preeclampsia Urogenital Diseases Vascular Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of North Carolina Women's Hospital

Chapel Hill, North Carolina, 27599-7516, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Maternal age 18-45 years
Informed written consent
Preeclampsia or new onset hypertension between 24-32 completed weeks' gestation

Hypertensive complications of pregnancy defined as new onset systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg on two occasions 6 hours apart; OR > 300 mg proteinuria on 24 hour urine collection OR urine P/C ratio >0.3;
Dating criteria based on menstrual dating confirmed by first or second trimester ultrasound OR second trimester ultrasound if menstrual dating unavailable;
Deemed clinically stable by primary clinician and candidate for expectant management (delayed delivery);
Maternal liver function tests < 3x ULN
Maternal platelet count > 100,000 mm3
Fetal well-being established by estimated fetal weight > 5th %tile; normal amniotic fluid volume (MVP > 2 cm); normal Umbilical Artery Dopplers; AND reactive NST(non-stress test) or BPP (biophysical profile) > 6
Plan for expectant management until delivery
Delivery not anticipated within first 48 hours

Exclusion criteria

Preeclampsia < 24 or > 33 weeks' gestation;
Suspected fetal structural or chromosomal abnormality;
Pre-existing renal disease (creatinine > 1.5 mg/dL)
Pre-existing vascular disease (systemic lupus; cardiac disease;)
Plan for delivery within 48 hours
Any pre-existing medical condition that would increase risk for liver toxicity (e.g. hepatitis B or C; HIV)
Evidence of cerebral dysfunction (seizures; cerebral edema on CT/MRI; headache unresolved with oral analgesics)
Pulmonary edema
HELLP (hemolysis, elevated liver enzymes, low platelets syndrome)
Evidence of liver dysfunction (LFTs > 3x ULN)
Thrombocytopenia (platelets < 100,000 mm3)
Evidence of fetal compromise: EFW(estimated fetal weight) < 5th percentile; BPP < 6; absent or reverse diastolic UA blood flow; 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

Treatment and study plan

Nicotinamide 500 mg

Drug

Nicotinamide 500 mg taken by mouth each morning

Other names: Vitamin B3 amide

Nicotinamide 1000 mg

Drug

Nicotinamide 1000 mg taken by mouth each morning

Other names: Vitamin B3 amide

Primary outcomes

Number of Participants With Adverse Events

Time frame: Within 48 hours of dosing

Specific adverse events were Maternal liver toxicity, defined as > 3x ULN of ALT(Alanine amniotransferase) or AST (Aspartate amniotransferase), maternal report of side effects, and fetal adverse effects.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

North Carolina Translational and Clinical Sciences Institute

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Aug 11, 2014
Registry last updated: Nov 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed