Trial · NCT03419364
Study of Nicotinamide in Early Onset Preeclampsia
NCT03419364, Phase 2, Completed, University of North Carolina, Chapel Hill; results first posted 2022-09-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Nicotinamide in Early Onset Preeclampsia. Trials, record NCT03419364. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03419364
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Nicotinamide in Early Onset Preeclampsia
- NCT number
- NCT03419364
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Pre-Eclampsia, Pregnancy Related
- Interventions
- nicotinamide
- First posted
- 2018-02-01
- Last updated
- 2022-09-08
- Results first posted
- 2022-09-08
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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. |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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. |
| Secondary | Percentage of Fetuses With Biophysical Profile < 6 | From initial administration of study agent until 24 hours post last dose |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean Arterial Blood Pressure (MAP) | Baseline, 48 hours | mmHg | MEAN | |
| SECONDARY | 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 | Healthy women were not at risk for liver toxicity and therefore were not assessed for ALT. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Healthy women were not at risk for liver toxicity and therefore were not assessed for AST. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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 participants | NUMBER | |
| SECONDARY | 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 participants | NUMBER | |
| SECONDARY | 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 | Healthy women were not at risk for anemia and therefore were not assessed for Hematocrit. | percentage of participants | NUMBER |
| SECONDARY | 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 | Healthy women were not at risk for oliguria and therefore were not assessed for urine output. | percentage of participants | NUMBER |
| SECONDARY | 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 | Healthy women were not at risk for placental insufficiency and therefore did not have a non stress test. | percentage of fetuses | NUMBER |
| SECONDARY | Percentage of Fetuses With Biophysical Profile < 6 | From initial administration of study agent until 24 hours post last dose | Data only collected if indicated and performed as part of clinical care. No primary care providers felt this test was indicated. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Arterial Blood Pressure (MAP) | Nicotinamide - Pre-eclampsia | 0 | Standard Deviation 9 | mmHg | |
| Change in Mean Arterial Blood Pressure (MAP) | Nicotinamide - Healthy Pregnant | 2 | Standard Deviation 9 | mmHg | |
| Change in Mean Arterial Blood Pressure (MAP) | Nicotinamide - Healthy Non-Pregnant | 4 | Standard Deviation 6 | mmHg | |
| Number of Participants With Alanine Aminotransferase (ALT) =/> 3x Upper Limit of Normal (ULN) | Nicotinamide - Pre-eclampsia | 0 | Participants | ||
| Number of Participants With Aspartate Aminotransferase (AST) =/> 3x Upper Limit of Normal (ULN) | Nicotinamide - Pre-eclampsia | 0 | Participants | ||
| Number of Participants With Maternal Side Effects | Nicotinamide - Pre-eclampsia | 0 | Participants | ||
| Number of Participants With Maternal Side Effects | Nicotinamide - Healthy Pregnant | 0 | Participants | ||
| Number of Participants With Maternal Side Effects | Nicotinamide - Healthy Non-Pregnant | 0 | Participants | ||
| Percentage of Women Maternal Abdominal Tenderness | Nicotinamide - Pre-eclampsia | 0 | percentage of participants | ||
| Percentage of Women Maternal Abdominal Tenderness | Nicotinamide - Healthy Pregnant | 0 | percentage of participants |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nicotinamide - Pre-eclampsia | 11 | |
| Overall Study | STARTED | Nicotinamide - Healthy Pregnant | 6 | |
| Overall Study | STARTED | Nicotinamide - Healthy Non-Pregnant | 6 | |
| Overall Study | Signed Consent | Nicotinamide - Pre-eclampsia | 11 | |
| Overall Study | Signed Consent | Nicotinamide - Healthy Pregnant | 6 | |
| Overall Study | Signed Consent | Nicotinamide - Healthy Non-Pregnant | 6 | |
| Overall Study | Received Intervention | Nicotinamide - Pre-eclampsia | 9 | |
| Overall Study | Received Intervention | Nicotinamide - Healthy Pregnant | 6 | |
| Overall Study | Received Intervention | Nicotinamide - Healthy Non-Pregnant | 6 | |
| Overall Study | COMPLETED | Nicotinamide - Pre-eclampsia | 9 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nicotinamide - Pre-eclampsia | 0 | 9 |
| Total, all-cause mortality | Nicotinamide - Healthy Pregnant | 0 | 6 |
| Total, all-cause mortality | Nicotinamide - Healthy Non-Pregnant | 0 | 6 |
| Total, other adverse events | Nicotinamide - Pre-eclampsia | 0 | 9 |
| Total, other adverse events | Nicotinamide - Healthy Pregnant | 0 | 6 |
| Total, other adverse events | Nicotinamide - Healthy Non-Pregnant | 0 | 6 |
| Total, serious adverse events | Nicotinamide - Pre-eclampsia | 0 | 9 |
| Total, serious adverse events | Nicotinamide - Healthy Pregnant | 0 | 6 |
| Total, serious adverse events | Nicotinamide - Healthy Non-Pregnant | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R03HD092370 | Phase II Study of Nicotinamide (vitamin B3-amide) in Early-Onset Preeclampsia | BOGGESS, KIM A | UNIV OF NORTH CAROLINA CHAPEL HILL | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2017 to 2018 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03419364
GET https://conductscience.org/api/trials/v1/NCT03419364/results?page=2