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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 is a NA study that has completed, run by University of Georgia. The registered enrollment target is 51 participants.

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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

Interventions

  • DIETARY_SUPPLEMENT Folic acid, 400 mcg/day
  • DIETARY_SUPPLEMENT Folic acid 800 mcg/day

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2014-05
Est. Completion 2017-12
Phase NA

Sponsor

University of Georgia

59 total trials

What the Registry Record Tells You About NCT02124642

The ClinicalTrials.gov registry entry for NCT02124642 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Georgia, which has 59 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Folic acid, 400 mcg/day is the first listed.

NCT02124642 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.