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| Name | Class |
|---|---|
| North Carolina Translational and Clinical Sciences Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotinamide 500 mg | Experimental | Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first. |
|
| Nicotinamide 1000 mg | Experimental | Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinamide 500 mg | Drug | Nicotinamide 500 mg taken by mouth each morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | 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. | Within 48 hours of dosing |
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Inclusion Criteria:
Maternal age 18-45 years
Informed written consent
Preeclampsia or new onset hypertension between 24-32 completed weeks' gestation
Maternal liver function tests < 3x ULN
Maternal platelet count > 100,000 mm3
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
Plan for expectant management until delivery
Delivery not anticipated within first 48 hours
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim A Boggess, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Women's Hospital | Chapel Hill | North Carolina | 27599-7516 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotinamide 500 mg | Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first. |
| FG001 | Nicotinamide 1000 mg | Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotinamide 500 mg | Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first. |
| BG001 | Nicotinamide 1000 mg | Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | 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. | Posted | Number | participants | Within 48 hours of dosing |
|
During study agent administration (up to 14 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nicotinamide 500 mg | Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal failure | Renal and urinary disorders | Non-systematic Assessment | Subject #5 required dialysis following delivery of her infant. Her serum creatinine was normal at enrollment and throughout study agent administration. She developed renal failure following delivery, which required 2 dialysis treatments. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kim Boggess MD Principal Investigator | UNC at Chapel Hill | 919-966-1601 | kboggess@med.unc.edu |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D006973 | Hypertension |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D009536 | Niacinamide |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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Phase 1 dose escalation study
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| Nicotinamide 1000 mg | Drug | Nicotinamide 1000 mg taken by mouth each morning |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 5 |
| 2 |
| 5 |
| 0 |
| 5 |
| EG001 | Nicotinamide 1000 mg | Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first. | 0 | 5 | 0 | 5 | 0 | 5 |
|
| Elevated LFTs | Hepatobiliary disorders | Non-systematic Assessment | Subject #4 had elevated LFTs < 24 hours after first dose of study agent. This was believed to be due to the disease process and thus the primary clinical provider opted to proceed with infant delivery, therefore study agent was discontinued. |
|
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| D002318 | Cardiovascular Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |