Study of Nicotinamide in Early Onset Preeclampsia

NCT ID: NCT03419364

Last Updated: 2022-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2021-08-31

Brief Summary

Phase II Study of 2.5 gm of nicotinamide, given daily in 3 divided doses, to measure effect on maternal blood pressure in women with early onset preeclampsia and to determine peak and trough levels of nicotinamide. We will compare peak and trough levels in healthy non-pregnant and healthy pregnant participants.

Detailed Description

See brief summary above

Conditions

Pre-Eclampsia; Pregnancy Related

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nicotinamide - pre-eclampsia

All participants will receive study agent

Group Type: EXPERIMENTAL

nicotinamide

Intervention Type: DRUG

2.5 gm nicotinamide given orally in 3 divided doses: 1000 mg in morning and evening, 500 mg at noon/midday

Nicotinamide - healthy pregnant

All participants will receive study agent 1000mg in single dose

Group Type: EXPERIMENTAL

nicotinamide

Intervention Type: DRUG

2.5 gm nicotinamide given orally in 3 divided doses: 1000 mg in morning and evening, 500 mg at noon/midday

Healthy Non-Pregnant

All participants will receive study agent 1000mg in single dose

Group Type: EXPERIMENTAL

nicotinamide

Intervention Type: DRUG

2.5 gm nicotinamide given orally in 3 divided doses: 1000 mg in morning and evening, 500 mg at noon/midday

Interventions

nicotinamide

2.5 gm nicotinamide given orally in 3 divided doses: 1000 mg in morning and evening, 500 mg at noon/midday

Intervention Type: DRUG

Other Intervention Names

niacinamide

Eligibility Criteria

Inclusion Criteria

• Maternal age 18-55 years
• Singleton pregnancy with no known fetal anomalies
• Early-onset preeclampsia OR early-onset severe gestational hypertension defined as:

• Early-onset: between 24 weeks 0 days and -33 weeks 3 days, based on menstrual dating confirmed by first or second trimester ultrasound OR second trimester ultrasound if menstrual dating unavailable;
• Preeclampsia:
• New onset hypertension and proteinuria, with systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg on two occasions 6 hours apart and > 300 mg proteinuria on 24 hour urine collection OR urine P/C ratio >0.3;
• New onset hypertension and NO proteinuria, with systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg on two occasions 6 hours apart and one or more of the following: serum creatinine >1.1 mg/dL or doubling from baseline ,or central nervous system symptoms or visual changes
• Severe preeclampsia defined as new onset systolic BP > 160 mm Hg and/or diastolic BP > 105 with proteinuria as above or or without proteinuria and one or more of the following criteria listed above

• Candidate for expectant management for at least 48 hours
• Deemed clinically stable by primary clinician and candidate for expectant management (delayed delivery) for at least 48 hours;
• Maternal liver function tests < 2x ULN
• Maternal platelet count > 100,000 mm³
• Planned expectant management
• Pre-existing medical diseases such as hypertension, diabetes, endocrine disorders, gastrointestinal diseases, are well controlled
• Fetal well-being established by estimated fetal weight > 5th %tile; normal amniotic fluid volume (MVP > 2 cm); normal Umbilical Artery (UA) Dopplers; or reactive Non Stress Test (NST) or Biophysical Profile (BPP) > 6
• Delivery not anticipated within 48 hours of enrollment

Exclusion Criteria

• Pre-existing renal disease (creatinine > 1.5 mg/dL)
• Any pre-existing medical condition that would increase risk for liver toxicity (e.g. hepatitis B or C; HIV; Isoniazid (INH) use)
• Eclampsia; cerebral edema on CT/MRI; headache unrelieved by analgesics
• Evidence of liver dysfunction (LFTs > 2x ULN)
• Thrombocytopenia (platelets < 100,000 mm³)
• Pulmonary edema
• HELLP syndrome
• Evidence of fetal compromise: Estimated Fetal Weight (EFW) < 5th percentile; or BPP < 6; or absent or reverse diastolic UA blood flow; or 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kim Boggess, MD

Role: PRINCIPAL_INVESTIGATOR

UNC_Chapel Hill

Locations

UNC at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R03HD092370-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-0693

Identifier Type: -

Identifier Source: org_study_id