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Effect of Maternal Choline Intake on Choline Status and Health Biomarkers During Pregnancy and Lactation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01127022
Recruitment Status : Completed
First Posted : May 20, 2010
Last Update Posted : September 18, 2013
Sponsor:
Collaborators:
American Egg Board
National Cattlemen's Beef Association
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
Cornell University

Brief Summary:
The purpose of this study is to investigate the effect of varied maternal choline intake on maternal/fetal biomarkers of choline status, genomic expression and metabolomic profiling.

Condition or disease Intervention/treatment Phase
Pregnancy Lactation Dietary Supplement: choline chloride Dietary Supplement: Choline Chloride Not Applicable

Detailed Description:
Choline is a micronutrient used for the structural integrity of cell membranes, lipid transport/metabolism, methylation reactions and cholinergic neurotransmission. Prenatal and early postnatal choline exposure plays a critical role in brain development and cognition based on animal data. Although it is recognized that choline use is particularly high during pregnancy and lactation, the level of choline intake needed to optimize maternal and fetal health outcomes is unknown. The primary objective of this study was to investigate the metabolic and genomic effects of two doses of choline intake, 450 mg/d (the adequate intake level for pregnant women) and 900 mg/d in pregnant, lactating, and nonpregnant control women. A secondary objective was to examine the effect of extra maternal choline intake on the child's cognitive performance (i.e, learning, memory and attention). To accomplish these objectives, pregnant women (wk 27 gestation), nonpregnant control women, and lactating women consumed controlled choline intakes of 480 or 930 mg/d for 10 to 12 weeks. The basal diet provided 380 mg/d; supplemental choline chloride, 100 or 550 mg/d, was used to achieve the target intake levels. During the last half of the study, a small portion (~ 20%) of the total choline intake was derived from deuterium labeled choline, a stable isotope. Blood, urine and/or breast milk were collected at baseline and at select timepoints throughout the study duration. For pregnant women, a maternal blood sample was obtained at the time of delivery along with a cord blood sample and the placental tissue. Genomic and metabolomic profiling were performed on the collected biological samples along with specific measurements of choline status. Non-invasive tests assessing cognitive function were performed on the children of the pregnant and lactating study participants. This controlled feeding study has also been extended to investigate dose-response relationships for other micronutrients including folate, vitamin B12, vitamin D, and biotin.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Maternal Choline Intake on Maternal/Fetal Biomarkers of Choline Status
Study Start Date : January 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 480 mg/d choline intake
480 mg/d choline derived from the diet [380 mg choline/d] plus supplemental choline chloride [100 mg choline/d]
Dietary Supplement: choline chloride
Women will consume a diet providing 380 mg/d total choline plus 100 mg/d supplemental choline [from choline chloride] for a total choline intake of 480 mg/d. The choline chloride will be administered in cran-grape juice.

Experimental: 930 mg/d choline intake
930 mg/d choline derived from the diet [380 mg choline/d] plus supplemental choline chloride [550 mg choline/d]
Dietary Supplement: Choline Chloride
Women will consume a diet providing 380 mg/d total choline plus 550 mg/d supplemental choline [from choline chloride] for a total choline intake of 930 mg/d. The choline chloride will be administered in cran-grape juice.




Primary Outcome Measures :
  1. Maternal biomarkers of choline status [ Time Frame: 10-12 Weeks ]

Secondary Outcome Measures :
  1. Genomic expression as function of maternal choline intake [ Time Frame: 10-12 Weeks ]
  2. Cognitive performance in children of study participants [ Time Frame: 12 months ]
  3. Metabolomic profiling as a function of maternal choline intake [ Time Frame: 10-12 Weeks ]
  4. Biomarkers for additional micronutrients [ Time Frame: 10-12 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant (wk 27 gestation) or lactating (postnatal day 30) or nonpregnant
  • Healthy
  • Non-smoker

Exclusion Criteria:

  • Liver or kidney problems
  • Alcohol or illegal drug misuse/abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01127022


Locations
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United States, New York
Human Metabolic Research Unit, Cornell University
Ithaca, New York, United States, 14853
Sponsors and Collaborators
Cornell University
American Egg Board
National Cattlemen's Beef Association
USDA Beltsville Human Nutrition Research Center
Investigators
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Principal Investigator: Marie A Caudill, PhD, RD Cornell University

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT01127022    
Other Study ID Numbers: OSP No: 59370, 57100, 58222
First Posted: May 20, 2010    Key Record Dates
Last Update Posted: September 18, 2013
Last Verified: September 2013
Keywords provided by Cornell University:
Pregnancy
Lactation
Choline
Cognition
Biomarkers
Additional relevant MeSH terms:
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Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents