Phase I Study of Nicotinamide for Early Onset Preeclampsia

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 3, 2015

Interventions

  • Drug: Nicotinamide 500 mg
    • Nicotinamide 500 mg taken by mouth each morning
  • Drug: Nicotinamide 1000 mg
    • Nicotinamide 1000 mg taken by mouth each morning

Arms, Groups and Cohorts

  • Experimental: Nicotinamide 500 mg
    • Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first.
  • Experimental: Nicotinamide 1000 mg
    • Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

1. Maternal age 18-45 years 2. Informed written consent 3. Preeclampsia or new onset hypertension between 24-32 completed weeks' gestation 1. 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; 2. Dating criteria based on menstrual dating confirmed by first or second trimester ultrasound OR second trimester ultrasound if menstrual dating unavailable; 3. Deemed clinically stable by primary clinician and candidate for expectant management (delayed delivery); 4. Maternal liver function tests < 3x ULN 5. Maternal platelet count > 100,000 mm3 6. 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 7. Plan for expectant management until delivery 8. Delivery not anticipated within first 48 hours Exclusion Criteria:

1. Preeclampsia < 24 or > 33 weeks' gestation; 2. Suspected fetal structural or chromosomal abnormality; 3. Pre-existing renal disease (creatinine > 1.5 mg/dL) 4. Pre-existing vascular disease (systemic lupus; cardiac disease;) 5. Plan for delivery within 48 hours 6. Any pre-existing medical condition that would increase risk for liver toxicity (e.g. hepatitis B or C; HIV) 7. Evidence of cerebral dysfunction (seizures; cerebral edema on CT/MRI; headache unresolved with oral analgesics) 8. Pulmonary edema 9. HELLP (hemolysis, elevated liver enzymes, low platelets syndrome) 10. Evidence of liver dysfunction (LFTs > 3x ULN) 11. Thrombocytopenia (platelets < 100,000 mm3) 12. Evidence of fetal compromise: EFW(estimated fetal weight) < 5th percentile; BPP < 6; absent or reverse diastolic UA blood flow; oligohydramnios (MVP < 2 cm) 13. Placental abruption defined as unexplained vaginal bleeding 14. Preterm labor defined as regular contractions and cervical change 15. Any condition deemed by the investigator to be a risk to mother or fetus in completion of the study 16. Any condition deemed by the investigator to require delivery within 48 hours

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of North Carolina, Chapel Hill
  • Collaborator
    • North Carolina Translational and Clinical Sciences Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kim A Boggess, MD, Principal Investigator, University of North Carolina, Chapel Hill

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