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

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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

Tracking Information
First Submitted Date  ICMJE May 17, 2010
First Posted Date  ICMJE May 20, 2010
Last Update Posted Date September 18, 2013
Study Start Date  ICMJE January 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2013)
Maternal biomarkers of choline status [ Time Frame: 10-12 Weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2010)
Maternal biomarkers of choline status [ Time Frame: 12 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2013)
  • Genomic expression as function of maternal choline intake [ Time Frame: 10-12 Weeks ]
  • Cognitive performance in children of study participants [ Time Frame: 12 months ]
  • Metabolomic profiling as a function of maternal choline intake [ Time Frame: 10-12 Weeks ]
  • Biomarkers for additional micronutrients [ Time Frame: 10-12 Weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2010)
  • Genomic expression as function of maternal choline intake [ Time Frame: 12 Weeks ]
  • Cognitive performance in children of study participants [ Time Frame: 12 months ]
  • Metabolomic profiling as a function of maternal choline intake [ Time Frame: 12 Weeks ]
  • Biomarkers for additional micronutrients [ Time Frame: 12 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Maternal Choline Intake on Choline Status and Health Biomarkers During Pregnancy and Lactation
Official Title  ICMJE Effect of Maternal Choline Intake on Maternal/Fetal Biomarkers of Choline Status
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Pregnancy
  • Lactation
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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]
    Intervention: Dietary Supplement: choline chloride
  • 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]
    Intervention: Dietary Supplement: Choline Chloride
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2013)
82
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2010)
76
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01127022
Other Study ID Numbers  ICMJE OSP No: 59370, 57100, 58222
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cornell University
Study Sponsor  ICMJE Cornell University
Collaborators  ICMJE
  • American Egg Board
  • National Cattlemen's Beef Association
  • USDA Beltsville Human Nutrition Research Center
Investigators  ICMJE
Principal Investigator: Marie A Caudill, PhD, RD Cornell University
PRS Account Cornell University
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP