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| ID | Type | Description | Link |
|---|---|---|---|
| 1R03HD092370-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
See brief summary above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotinamide - pre-eclampsia | Experimental | All participants will receive study agent |
|
| Nicotinamide - healthy pregnant | Experimental | All participants will receive study agent 1000mg in single dose |
|
| Healthy Non-Pregnant | Experimental | All participants will receive study agent 1000mg in single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nicotinamide | Drug | 2.5 gm nicotinamide given orally in 3 divided doses: 1000 mg in morning and evening, 500 mg at noon/midday |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Arterial Blood Pressure (MAP) | 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. | Baseline, 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
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Diagnosis and 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:
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
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
Study of pregnant and non-pregnant women only
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| Name | Affiliation | Role |
|---|---|---|
| Kim Boggess, MD | UNC_Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotinamide - Pre-eclampsia | All participants will receive study agent nicotinamide: 2.5 gm nicotinamide given orally in 3 divided doses: 1000 mg in morning and evening, 500 mg at noon/midday |
| FG001 | Nicotinamide - Healthy Pregnant | All participants will receive study agent 1000 mg in single dose nicotinamide: 1000 mg nicotinamide in morning |
| FG002 | Nicotinamide - Healthy Non-Pregnant | All participants will receive study agent 1000 mg in single dose nicotinamide: 1000 mg nicotinamide in morning |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotinamide - Pre-eclampsia | All participants will receive study agent nicotinamide: 2.5 gm nicotinamide given orally in 3 divided doses: 1000 mg in morning and evening, 500 mg at noon/midday |
| BG001 | Nicotinamide - Healthy Pregnant |
| 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 | Change in Mean Arterial Blood Pressure (MAP) | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, 48 hours |
|
From signing of informed consent up to 30 days after infant delivery, ranging from 31 to 58 days total.
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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 - Pre-eclampsia | All participants will receive study agent nicotinamide: 2.5 gm nicotinamide given orally in 3 divided doses: 1000 mg in morning and evening, 500 mg at noon/midday |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kim Boggess, MD | University of North Carolina at Chapel Hill | 919-966-1601 | kboggess@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2019 | Jun 22, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital 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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All participants will receive study agent. 2.5 gm nicotinamide given orally in 3 divided doses (1000 in morning, 500 in afternoon, 1000 at bedtime).
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|
| Number of Participants With Maternal Side Effects | Maternal side effects are defined as: facial erythema, hives, sore mouth, dry hair, fatigue, flushing, headache, nausea, and heart burn. | From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks |
| 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 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 |
| 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 |
| Percentage of Fetuses With Category III Non Stress Test Results | 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. | From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks |
| Percentage of Fetuses With Biophysical Profile < 6 | From initial administration of study agent until 24 hours post last dose |
| Mean Peak Nicotinamide Level | 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. | at 1 hour post 1000 mg nicotinamide administration on Day 1 |
| Mean Trough Concentration Nicotinamide Administration | 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. | 8 hours after the 8 a.m. 1000 mg nicotimamide administration on Day 1 |
All participants will receive study agent 1000 mg in single dose nicotinamide: 1000 mg nicotinamide in morning |
| BG002 | Nicotinamide - Healthy Non-Pregnant | All participants will receive study agent 1000 mg in single dose nicotinamide: 1000 mg nicotinamide in morning |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Nicotinamide - Healthy Non-Pregnant | All participants will receive study agent 1000 mg in single dose nicotinamide: 1000 mg nicotinamide in morning |
|
|
| Secondary | Number of Participants With Alanine Aminotransferase (ALT) =/> 3x Upper Limit of Normal (ULN) | Healthy women were not at risk for liver toxicity and therefore were not assessed for ALT. | Posted | Count of Participants | Participants | Within 24 hours of any dose, up to a maximum 4 weeks |
|
|
|
| Secondary | Number of Participants With Aspartate Aminotransferase (AST) =/> 3x Upper Limit of Normal (ULN) | Healthy women were not at risk for liver toxicity and therefore were not assessed for AST. | Posted | Count of Participants | Participants | Within 24 hours of any dose, up to a maximum 4 weeks |
|
|
|
| Secondary | Number of Participants With Maternal Side Effects | Maternal side effects are defined as: facial erythema, hives, sore mouth, dry hair, fatigue, flushing, headache, nausea, and heart burn. | Posted | Count of Participants | Participants | From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks |
|
|
|
| Secondary | Percentage of Women Maternal Abdominal Tenderness | Posted | Number | percentage of participants | From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks |
|
|
|
| Secondary | Percentage of Women With Headache Unrelieved by Oral Analgesics | Posted | Number | percentage of participants | From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks |
|
|
|
| Secondary | Percentage of Women With Hematocrit Decrease of More Than 3% | Healthy women were not at risk for anemia and therefore were not assessed for Hematocrit. | Posted | Number | percentage of participants | From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks |
|
|
|
| Secondary | Percentage of Women With Less Than 500 cc Urine Output in 24 Hours | Healthy women were not at risk for oliguria and therefore were not assessed for urine output. | Posted | Number | percentage of participants | From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks |
|
|
|
| Secondary | Percentage of Fetuses With Category III Non Stress Test Results | 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. | Healthy women were not at risk for placental insufficiency and therefore did not have a non stress test. | Posted | Number | percentage of fetuses | From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks |
|
|
|
| Secondary | Percentage of Fetuses With Biophysical Profile < 6 | Data only collected if indicated and performed as part of clinical care. No primary care providers felt this test was indicated. | Posted | From initial administration of study agent until 24 hours post last dose |
|
|
| Secondary | Mean Peak Nicotinamide Level | 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. | Data reported for all participants who had blood collected. | Posted | Mean | Standard Deviation | ng/mL | at 1 hour post 1000 mg nicotinamide administration on Day 1 |
|
|
|
| Secondary | Mean Trough Concentration Nicotinamide Administration | 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. | Data reported for all participants who had blood collected. | Posted | Mean | Standard Deviation | ng/mL | 8 hours after the 8 a.m. 1000 mg nicotimamide administration on Day 1 |
|
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|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Nicotinamide - Healthy Pregnant | All participants will receive study agent 1000 mg in single dose nicotinamide: 1000 mg nicotinamide in morning | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Nicotinamide - Healthy Non-Pregnant | All participants will receive study agent 1000 mg in single dose nicotinamide: 1000 mg nicotinamide in morning | 0 | 6 | 0 | 6 | 0 | 6 |
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| D006573 |
| Heterocyclic Compounds, 1-Ring |