Folic Acid Supplementation in Pregnant Women: Dose Response
Public ClinicalTrials.gov record NCT02124642. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT02124642
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 51 participants
Conditions and interventions
Conditions
Interventions
- Folic acid, 400 mcg/day Dietary Supplement
- Folic acid 800 mcg/day Dietary Supplement
Dietary Supplement
Eligibility (public fields only)
- Age range
- 18 Years to 40 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2014
- Primary completion
- Nov 30, 2015
- Completion
- Nov 30, 2017
- Last update posted
- Mar 4, 2018
2014 – 2017
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Athens Regional Medical Center Midwifery Practice | Athens | Georgia | 30606 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02124642, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 4, 2018 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02124642 live on ClinicalTrials.gov.