Phase I Study of Nicotinamide for Early Onset Preeclampsia

NCT ID: NCT02213094

Last Updated: 2018-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2015-12-03

Brief Summary

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.

Conditions

Pregnancy Induced Hypertension; Superimposed Preeclampsia; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Nicotinamide 500 mg

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

Group Type: EXPERIMENTAL

Nicotinamide 500 mg

Intervention Type: DRUG

Nicotinamide 500 mg taken by mouth each morning

Nicotinamide 1000 mg

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

Group Type: EXPERIMENTAL

Nicotinamide 1000 mg

Intervention Type: DRUG

Nicotinamide 1000 mg taken by mouth each morning

Interventions

Nicotinamide 500 mg

Nicotinamide 500 mg taken by mouth each morning

Intervention Type: DRUG

Nicotinamide 1000 mg

Nicotinamide 1000 mg taken by mouth each morning

Intervention Type: DRUG

Other Intervention Names

Vitamin B3 amide; Vitamin B3 amide

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

North Carolina Translational and Clinical Sciences Institute

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kim A Boggess, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina Women's Hospital

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

13-2203

Identifier Type: -

Identifier Source: org_study_id