Study of Nicotinamide in Early Onset Preeclampsia

Phase 2

Completed

• Conditions: Pregnancy Related; Pre-Eclampsia
• Interventions: Drug: nicotinamide

• Registration Number: NCT03419364
• Lead Sponsor: University of North Carolina, Chapel Hill

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

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2018-01-26
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2022-07
• Results First Submitted: 2022-07-01
• Results First Submitted QC: 2022-08-16
• Last Update Submitted: 2022-08-16
• Results First Posted: 2022-09-08
• Last Update Posted: 2022-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nicotinamide - pre-eclampsia	nicotinamide	All participants will receive study agent
Nicotinamide - healthy pregnant	nicotinamide	All participants will receive study agent 1000mg in single dose
Healthy Non-Pregnant	nicotinamide	All participants will receive study agent 1000mg in single dose

Primary Outcome Measures

Name	Time	Method
Change in Mean Arterial Blood Pressure (MAP)	Baseline, 48 hours	Blood pressure (mmHg) will be used to observe the effect of nicotinamide. The highest MAP (defined as the highest MAP within the 24 hour period prior to the administration of study agent) and the highest MAP through 24 hours after study drug administration.

Secondary Outcome Measures

Name	Time	Method
Percentage of Fetuses With Category III Non Stress Test Results	From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks	A Non Stress Test is a determination of the current well-being of the fetus, as measured by the fetal heart rate. Category I indicates that the fetus is in a state of well-being and is tolerating the intrauterine environment. Category II indicates a fetal heart rate that is showing some signs of distress. In this instance, obstetric providers will try to improve the intrauterine environment to allow the pregnancy to continue. Category III relates to a fetus whose well-being is compromised - usually requiring rapid intervention, ie expedient delivery.
Percentage of Fetuses With Biophysical Profile < 6	From initial administration of study agent until 24 hours post last dose
Mean Peak Nicotinamide Level	at 1 hour post 1000 mg nicotinamide administration on Day 1	The mean was calculated for each group using blood samples drawn on Day 1 at 1 hour post 1000 mg nicotinamide administration routinely given at 8 a.m. Peak nicotinamide level expected at 1 hour post dose.
Number of Participants With Alanine Aminotransferase (ALT) =/> 3x Upper Limit of Normal (ULN)	Within 24 hours of any dose, up to a maximum 4 weeks
Percentage of Women With Hematocrit Decrease of More Than 3%	From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks
Mean Trough Concentration Nicotinamide Administration	8 hours after the 8 a.m. 1000 mg nicotimamide administration on Day 1	The mean was calculated for each group for blood samples drawn on Day 1 8 hours post 1000 mg nicotinamide administration routinely given at 8 a.m. Trough nicotinamide level is measured immediately prior to the next dose.
Percentage of Women Maternal Abdominal Tenderness	From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks
Percentage of Women With Headache Unrelieved by Oral Analgesics	From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks
Percentage of Women With Less Than 500 cc Urine Output in 24 Hours	From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks
Number of Participants With Aspartate Aminotransferase (AST) =/> 3x Upper Limit of Normal (ULN)	Within 24 hours of any dose, up to a maximum 4 weeks
Number of Participants With Maternal Side Effects	From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks	Maternal side effects are defined as: facial erythema, hives, sore mouth, dry hair, fatigue, flushing, headache, nausea, and heart burn.

Trial Locations

Locations (1)

UNC at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States