Pre-EclampsiaPhase 2NCT03419364
Study of Nicotinamide in Early Onset Preeclampsia
A Phase 2 study testing nicotinamide in people with Pre-Eclampsia and Pregnancy Related, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Pre-Eclampsia, Pregnancy Related
- What is being tested?
- nicotinamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 31 Aug 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Pre-existing renal disease (creatinine > 1.5 mg/dL)
- Any pre-existing medical condition that would increase risk for liver toxicity (e.g. hepatitis B or C; HIV; Isoniazid (INH) use)
- Eclampsia; cerebral edema on CT/MRI; headache unrelieved by analgesics
- Evidence of liver dysfunction (LFTs > 2x ULN)
- Thrombocytopenia (platelets < 100,000 mm³)
- Pulmonary edema
Show all 12Show fewer
- HELLP syndrome
- Evidence of fetal compromise: Estimated Fetal Weight (EFW) < 5th percentile; or BPP < 6; or absent or reverse diastolic UA blood flow; or oligohydramnios (MVP < 2 cm)
- Placental abruption defined as unexplained vaginal bleeding
- Preterm labor defined as regular contractions and cervical change
- Any condition deemed by the investigator to be a risk to mother or fetus in completion of the study
- Any condition deemed by the investigator to require delivery within 48 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Phase II Study of Nicotinamide in Early Onset Preeclampsia
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.
Read the detailed description
See brief summary above
- Conditions
- Pre-Eclampsia, Pregnancy Related
- Being tested
- nicotinamide
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicotinamideDrug
Also called niacinamide
2.5 gm nicotinamide given orally in 3 divided doses: 1000 mg in morning and evening, 500 mg at noon/midday
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide - pre-eclampsia | Experimental | All participants will receive study agent Receives: Drug: nicotinamide |
| Nicotinamide - healthy pregnant | Experimental | All participants will receive study agent 1000mg in single dose Receives: Drug: nicotinamide |
| Healthy Non-Pregnant | Experimental | All participants will receive study agent 1000mg in single dose Receives: Drug: nicotinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 48 hours
Secondary outcomes (11)
Number of Participants With Alanine Aminotransferase (ALT) =/> 3x Upper Limit of Normal (ULN)
Measured: 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)
Measured: Within 24 hours of any dose, up to a maximum 4 weeks
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.
Measured: 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
Measured: 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
Measured: 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%
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 8 hours after the 8 a.m. 1000 mg nicotimamide administration on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start1 Nov 2017
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Kim Boggess, MD, Principal investigator, UNC_Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419364
- Sponsor's protocol ID
- 17-0693
- Other IDs
- 1R03HD092370-01
- Status last verified
- Jul 2022
- First submitted
- 26 Jan 2018
- Last updated
- 8 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Nicotinamide in Early Onset Preeclampsia
- ClinicalTrials.gov ID
- NCT03419364
- Acronym / sponsor ID
- 17-0693
- Conditions
- Pre-Eclampsia, Pregnancy Related
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Posted 8 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See brief summary above
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide - pre-eclampsia | Experimental | Drug: nicotinamideAll participants will receive study agent |
| Nicotinamide - healthy pregnant | Experimental | Drug: nicotinamideAll participants will receive study agent 1000mg in single dose |
| Healthy Non-Pregnant | Experimental | Drug: nicotinamideAll participants will receive study agent 1000mg in single dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Pre-existing renal disease (creatinine > 1.5 mg/dL)
- Any pre-existing medical condition that would increase risk for liver toxicity (e.g. hepatitis B or C; HIV; Isoniazid (INH) use)
- Eclampsia; cerebral edema on CT/MRI; headache unrelieved by analgesics
- Evidence of liver dysfunction (LFTs > 2x ULN)
- Thrombocytopenia (platelets < 100,000 mm³)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nicotinamideAlso: niacinamide2.5 gm nicotinamide given orally in 3 divided doses: 1000 mg in morning and evening, 500 mg at noon/midday | Drug | Healthy Non-Pregnant, Nicotinamide - healthy pregnant, Nicotinamide - pre-eclampsia |
Primary outcome
Change in Mean Arterial Blood Pressure (MAP)
Time frame: 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.
11 secondary outcomes
Number of Participants With Alanine Aminotransferase (ALT) =/> 3x Upper Limit of Normal (ULN)
Time frame: 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)
Time frame: Within 24 hours of any dose, up to a maximum 4 weeks
Number of Participants With Maternal Side Effects
Time frame: 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
Time frame: 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
Time frame: 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%
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From initial administration of study agent until 24 hours post last dose
Mean Peak Nicotinamide Level
Time frame: at 1 hour post 1000 mg nicotinamide administration on Day 1
Mean Trough Concentration Nicotinamide Administration
Time frame: 8 hours after the 8 a.m. 1000 mg nicotimamide administration on Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Boggess, MD principal investigator
UNC_Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nicotinamide in people with Pre-Eclampsia and Pregnancy Related, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Arterial Blood Pressure (MAP) (time frame: Baseline, 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.