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
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