Trial · NCT02213094
Phase I Study of Nicotinamide for Early Onset Preeclampsia
NCT02213094, Phase 1, Completed, University of North Carolina, Chapel Hill; results first posted 2018-11-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I Study of Nicotinamide for Early Onset Preeclampsia. Trials, record NCT02213094. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02213094
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I Study of Nicotinamide for Early Onset Preeclampsia
- NCT number
- NCT02213094
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 10 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Pregnancy Induced Hypertension, Superimposed Preeclampsia, Hypertension
- Interventions
- Nicotinamide 500 mg, Nicotinamide 1000 mg
- First posted
- 2014-08-11
- Last updated
- 2018-11-02
- Results first posted
- 2018-11-02
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events | Within 48 hours of dosing | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | Nicotinamide 500 mg | 2 | participants | ||
| Number of Participants With Adverse Events | Nicotinamide 1000 mg | 0 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nicotinamide 500 mg | 5 | |
| Overall Study | STARTED | Nicotinamide 1000 mg | 5 | |
| Overall Study | COMPLETED | Nicotinamide 500 mg | 4 | |
| Overall Study | COMPLETED | Nicotinamide 1000 mg | 5 | |
| Overall Study | NOT COMPLETED | Nicotinamide 500 mg | 1 | |
| Overall Study | NOT COMPLETED | Nicotinamide 1000 mg | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Renal failure | Renal and urinary disorders | Nicotinamide 500 mg | 1 | 5 | 1 |
| serious | Renal failure | Renal and urinary disorders | Nicotinamide 1000 mg | 0 | 5 | 0 |
| serious | Elevated LFTs | Hepatobiliary disorders | Nicotinamide 500 mg | 1 | 5 | 1 |
| serious | Elevated LFTs | Hepatobiliary disorders | Nicotinamide 1000 mg | 0 | 5 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nicotinamide 500 mg | 0 | 5 |
| Total, all-cause mortality | Nicotinamide 1000 mg | 0 | 5 |
| Total, other adverse events | Nicotinamide 500 mg | 0 | 5 |
| Total, other adverse events | Nicotinamide 1000 mg | 0 | 5 |
| Total, serious adverse events | Nicotinamide 500 mg | 2 | 5 |
| Total, serious adverse events | Nicotinamide 1000 mg | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nicotinamide 500 mg vs Nicotinamide 1000 mg: deaths from any cause | Trial comparisons |
| Nicotinamide 500 mg vs Nicotinamide 1000 mg: Number of Participants With Adverse Events | Trial comparisons |
| Nicotinamide 500 mg vs Nicotinamide 1000 mg: serious adverse events | Trial comparisons |
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/NCT02213094
GET https://conductscience.org/api/trials/v1/NCT02213094/registered