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Nicotinamide Safety Study

Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pregnancy Induced Hypertension; Superimposed Preeclampsia; Hypertension

Intervention: Nicotinamide (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of North Carolina, Chapel Hill

Official(s) and/or principal investigator(s):
Kim A Boggess, MD, Principal Investigator, Affiliation: University of North Carolina, Chapel Hill

Overall contact:
Kim A Boggess, MD, Phone: 919-966-1601, Email: kboggess@med.unc.edu

Summary

This is an open labeled dose escalation safety study of vitamin B3-amide dietary supplementation in pregnant women with hypertensive complications of pregnancy. The investigators will enroll 5 pregnant women at 24-36 weeks' gestation with the diagnosis of hypertensive complications of pregnancy. If the woman is anticipated to remain undelivered for 48 hours after diagnosis she will receive vitamin B3-amide, 500 mg/day in a single daily dose, continuing for two weeks or until delivery, which ever occurs first. Maternal blood will be collected at baseline and 2 times per week to measure maternal LFTs and study markers (nicotinamide metabolites, sFlt-1-Soluble fms-like tyrosine kinase-1 and PlGF). The objective of this dose escalation safety study is to determine the safety of vitamin B3 amide dietary supplementation during expectant management of hypertensive complications of pregnancy.

Clinical Details

Official title: A Dose Escalation Safety Study of Vitamin B3 Amide Supplementation in Women With Hypertensive Complications of Pregnancy

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome:

Measurement of safety of vitamin B3-amide (nicotinamide) 500mg dietary supplementation during expectant management of EOP (early onset preeclampsia)

Measurement of safety of vitamin B3-amide (nicotinamide) 1000mg dietary supplementation during expectant management of EOP

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. Maternal age 18-45 years 2. Informed written consent 3. Preeclampsia or new onset hypertension between 24-36 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 > 36 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

Locations and Contacts

Kim A Boggess, MD, Phone: 919-966-1601, Email: kboggess@med.unc.edu

University of North Carolina Women's Hospital, Chapel Hill, North Carolina 27599, United States; Recruiting
Kim Boggess, MD, Phone: 919-966-1601, Email: kim_boggess@med.unc.edu

WakeMed Hospital, Raleigh, North Carolina, United States; Active, not recruiting

Additional Information

Starting date: October 2013
Last updated: April 8, 2015

Page last updated: August 23, 2015

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