Folic Acid Supplementation in Pregnant Women: Dose Response

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

Conditions

• Pregnancy

Interventions

DIETARY_SUPPLEMENT

Folic acid, 400 mcg/day

The supplement regime for this arm will consist of (1) a women's multivitamin/ multimineral (MVM) supplement containing 400 mcg folic acid, (2) a capsule containing 200 mg DHA and (3) a capsule formulated to contain 10 mg iron (which represents the difference in the amount of iron in the women's MVM formulation and that in prenatal MVM supplements).

DIETARY_SUPPLEMENT

Folic acid 800 mcg/day

The supplement regime for this arm will consist of (1) a women's multivitamin/ multimineral (MVM) supplement containing 400 mcg folic acid, (2) a capsule containing 200 mg DHA and (3) a capsule formulated to contain 10 mg iron (which represents the difference in the amount of iron in the women's MVM formulation and that in prenatal MVM supplements) and 400 mcg folic acid.

Sponsors & Collaborators

• University of Florida

  collaborator OTHER

• Emory University

  collaborator OTHER

• Cornell University

  collaborator OTHER

• University of Georgia

  lead OTHER

Principal Investigators

• Lynn B Bailey, PhD · University of Georgia

• Dorothy B Hausman, PhD · University of Georgia

• Hea Jin Park, PhD · University of Georgia

• Gail P A Kauwell, PhD, RDN · University of Florida

• Marie A Caudill, PhD, RD · Cornell University

• Alicia K Smith, PhD · Emory Univeristy

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-05-31

Primary Completion

2015-12-31

Completion

2017-12-31

Countries

• United States

Study Locations