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NCT02124642 · ClinicalTrials.gov registry record · NA
Folic Acid Supplementation in Pregnant Women: Dose Response
A NA study, sponsored by University of Georgia.
- Completed
- Registry status
- NA
- Development phase
- 51
- Enrollment target
NCT02124642: Completed NA study, sponsored by University of Georgia.
NCT02124642 is a NA study that has completed, run by University of Georgia. The registered enrollment target is 51 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02124642, a NA study, has completed, sponsored by University of Georgia.
- COMPLETED
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
Study Summary
The proposed study is a double-blind randomized controlled trial in healthy pregnant women (BMI 18.5 - 29.9 kg/m2, age 18 - 40 yr) receiving prenatal care at Athens Regional Midwifery clinic (ARMC). The primary goal of the proposed study is to determine relative changes in blood folate and DNA methylation levels in response to 2 different supplemental doses of folic acid one of which will provide the Institute of Medicine's recommended folate intake for pregnant women and the second will provide a higher dose as routinely taken by pregnant women in over-the-counter prenatal supplements. The specific aims of the study are: 1. to compare maternal serum and red blood cell (RBC) folate levels and % change in women taking either 400 or 800 mcg/day of supplemental folic acid from the first prenatal visit (\< 10 weeks) through delivery; 2. to compare the infant's cord blood folate levels in response to different maternal folic acid intakes (400 mcg/d vs 800 mcg/d); 3. to determine relative differences in the levels of oxidized folic acid in maternal and infant blood in response to 400 or 800 mcg/d folic acid dose, and 4. to determine genome wide and gene specific DNA methylation response in pregnant women receiving prenatal supplements containing either 400 or 800 mcg folic acid per day
Primary Outcome
Change in serum folate concentrations in response to supplementation during pregnancy with one of two levels of folic acid will be determined by microbiological assay using Lactobacillus rhamnosus. Cord blood serum folate at delivery will also be determined by the microbiological assay. Differences in serum folate response to the two levels of folic acid supplementation will be compared.
Interventions
- DIETARY_SUPPLEMENT Folic acid, 400 mcg/day
- DIETARY_SUPPLEMENT Folic acid 800 mcg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2014-05 |
| Est. Completion | 2017-12 |
| Phase | NA |
What the finished NCT02124642 record still lists
NCT02124642 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Folic acid, 400 mcg/day is the first listed.
NCT02124642 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02124642 about?
NCT02124642 is a clinical study titled "Folic Acid Supplementation in Pregnant Women: Dose Response". The proposed study is a double-blind randomized controlled trial in healthy pregnant women (BMI 18.5 - 29.9 kg/m2, age 18 - 40 yr) receiving prenatal care at Athens Regional Midwifery clinic (ARMC). The primary goal of the proposed study is to determine relative changes in blood folate and DNA meth...
What is the current status of trial NCT02124642?
This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2014-05. Estimated completion is 2017-12.
What interventions are being tested in trial NCT02124642?
The interventions under investigation include: Folic acid, 400 mcg/day (DIETARY_SUPPLEMENT), Folic acid 800 mcg/day (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02124642?
This trial is sponsored by University of Georgia, which has 59 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02124642's enrollment target sits among peer trials
51 1279th of 2000 higher than 722 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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