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Clinical Trials/NCT01127022
NCT01127022
Completed
Not Applicable

Effect of Maternal Choline Intake on Maternal/Fetal Biomarkers of Choline Status

Cornell University1 site in 1 country82 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Cornell University
Enrollment
82
Locations
1
Primary Endpoint
Maternal biomarkers of choline status
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
December 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Maternal biomarkers of choline status

Time Frame: 10-12 Weeks

Secondary Outcomes

  • Cognitive performance in children of study participants(12 months)
  • Biomarkers for additional micronutrients(10-12 Weeks)
  • Metabolomic profiling as a function of maternal choline intake(10-12 Weeks)
  • Genomic expression as function of maternal choline intake(10-12 Weeks)

Study Sites (1)

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