Synergy Between Choline and DHA
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|ClinicalTrials.gov Identifier: NCT03194659|
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : July 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Dietary Supplement: Choline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||All investigators interacting with participants will be masked to the study arm assignment. Only the Primary Investigator and Laboratory Manager (prepares supplements) will have access to participant's study assignment.|
|Primary Purpose:||Basic Science|
|Official Title:||Maternal Choline Supplementation and Its Impact on Docosahexaenoic Acid Supply in Human Pregnancy|
|Actual Study Start Date :||October 5, 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
No Intervention: Placebo
Administration of the deuterated choline chloride will take place in a grape juice cocktail solution. For individuals in the placebo arm of the trial, no additional choline chloride will be added to the cocktail.
Experimental: Supplemental Choline
Administration of the deuterated choline chloride will take place in a grape juice cocktail solution. For individuals in the placebo arm of the trial, supplemental choline chloride will be added to the cocktail.
Dietary Supplement: Choline
Choline 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.
- DHA-Containing Phosphatidylcholine Species in Circulating Erythrocytes [ Time Frame: Gestational Weeks 12-16 through Gestational Weeks 38-41 ]Phosphatidylcholine species contain 2 fatty acid tails; phosphatidylcholines containing DHA at either the sn-1 or sn-2 positions are found circulating in erythrocytes and serve as a long term marker of DHA status. Erythrocyte PC-DHA is partially supplied by albumin bound lysophosphatidylcholine enriched with DHA, a product of the phosphatidylethanolamine methyltransferase pathway in the liver . which has been shown to be sensitive to dietary choline intakes in non-pregnant women.
- Circulating labeled and unlabeled choline metabolites in maternal plasma [ Time Frame: Gestational Weeks 12-16 through Gestational Weeks 38-41 ]The concentrations and isotopic enrichments of choline and its metabolites (betaine, dimethylglycine,sarcosine, total phosphatidylcholine) will be determined in the maternal, placental and fetal compartments.
- The impact of dietary choline on total DHA concentrations in the maternal, fetal and placental compartments [ Time Frame: Gestational Weeks 12-16 through Gestational Weeks 38-41 ]The total concentrations of docosahexaenoic acid (DHA) will be measured in the maternal blood throughout this study. Additionally, at term, placenta and cord blood will be collected and analyzed for total DHA measurements.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194659
|Contact: Marie A. Caudill, PhDfirstname.lastname@example.org|
|Contact: Kevin C. Klattemail@example.com|
|United States, New York|
|Human Metabolic Research Unit, Cornell University||Recruiting|
|Ithaca, New York, United States, 14853|
|Contact: Erica Bender, MSN, CNM 607-255-9417 firstname.lastname@example.org|
|Principal Investigator: Marie A. Caudill, PhD|
|Principal Investigator:||Marie A. Caudill, PhD||Cornell University|