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Phase I Study of Nicotinamide for Early Onset Preeclampsia

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ClinicalTrials.gov Identifier: NCT02213094
Recruitment Status : Completed
First Posted : August 11, 2014
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Collaborator:
North Carolina Translational and Clinical Sciences Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Pregnancy Induced Hypertension Superimposed Preeclampsia Hypertension Drug: Nicotinamide 500 mg Drug: Nicotinamide 1000 mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Phase 1 dose escalation study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phase I Study of Nicotinamide for Early Onset Preeclampsia
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : December 3, 2015
Actual Study Completion Date : December 3, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nicotinamide 500 mg
Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first.
Drug: Nicotinamide 500 mg
Nicotinamide 500 mg taken by mouth each morning
Other Name: Vitamin B3 amide

Experimental: Nicotinamide 1000 mg
Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.
Drug: Nicotinamide 1000 mg
Nicotinamide 1000 mg taken by mouth each morning
Other Name: Vitamin B3 amide




Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: Within 48 hours of dosing ]
    Specific adverse events were Maternal liver toxicity, defined as > 3x ULN of ALT(Alanine amniotransferase) or AST (Aspartate amniotransferase), maternal report of side effects, and fetal adverse effects.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213094


Locations
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United States, North Carolina
University of North Carolina Women's Hospital
Chapel Hill, North Carolina, United States, 27599-7516
Sponsors and Collaborators
University of North Carolina, Chapel Hill
North Carolina Translational and Clinical Sciences Institute
Investigators
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Principal Investigator: Kim A Boggess, MD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02213094     History of Changes
Other Study ID Numbers: 13-2203
First Posted: August 11, 2014    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of North Carolina, Chapel Hill:
preeclampsia
pregnancy-induced hypertension
nicotinamide
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Vitamins
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents