Clinical Trials Directory

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UnknownNCT03194659

Synergy Between Choline and DHA

Maternal Choline Supplementation and Its Impact on Docosahexaenoic Acid Supply in Human Pregnancy

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Cornell University · Academic / Other
Sex
Female
Age
21 Years – 40 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to determine whether choline supplementation influences the availability of docosahexaenoic acid throughout pregnancy.

Detailed description

Metabolic synergy exists between choline, phospholipid, and polyunsaturated fatty acid metabolism. Previous evidence from our laboratory has shown that higher dietary choline intakes increase the amount of docosahexaenoic acid (DHA) incorporated into phosphatidylcholine (PC), as measured by PC-DHA concentrations in circulating erythrocytes. PC-DHA results from the production of PC through the phosphatidyl N-ethanolamine methyltransferase (PEMT) pathway and is critical for exporting fat from the liver to peripheral tissues. We are expanding this work to pregnant women, for whom DHA intake is critical to support the developing infant's growth, by undertaking a double blind, randomized controlled trial of choline supplementation (500mg) throughout the 2nd and 3rd trimesters of pregnancy. All women will consume 200mg of docosahexaenoic acid (DHA), a prenatal vitamin, and 25-50mg of deuterated choline (choline d9) daily throughout the duration of the trial. The use of a stable isotope will allow for modeling of choline dynamics throughout the 2nd and 3rd trimester of pregnancy, and calculate the activity of PEMT in pregnant women. Consenting participants will provide a baseline blood draw, followed by 2 additional blood draws throughout their pregnancies, and maternal/cord blood at birth, in addition to the placenta. This trial will test the hypothesis that choline supplementation increases the amount of PC-DHA in the blood of pregnant women and increase its supply to the developing fetus.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTCholineCholine chloride is a water soluble choline salt that will be provided in a juice solution to participants to be consumed daily. The intervention will increase dietary choline intake by 500mg/day.

Timeline

Start date
2017-10-05
Primary completion
2021-12-05
Completion
2021-12-05
First posted
2017-06-21
Last updated
2020-01-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03194659. Inclusion in this directory is not an endorsement.