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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01127022
Enrollment
82
Registered
2010-05-20
Start date
2009-01-31
Completion date
2011-12-31
Last updated
2013-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactation, Pregnancy

Keywords

Pregnancy, Lactation, Choline, Cognition, Biomarkers

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.

Interventions

DIETARY_SUPPLEMENTcholine 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_SUPPLEMENTCholine 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.

Sponsors

American Egg Board
CollaboratorOTHER
National Cattlemen's Beef Association, a contractor to the Beef Checkoff
CollaboratorINDUSTRY
USDA Beltsville Human Nutrition Research Center
CollaboratorFED
Cornell University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Maternal biomarkers of choline status10-12 Weeks

Secondary

MeasureTime frame
Genomic expression as function of maternal choline intake10-12 Weeks
Cognitive performance in children of study participants12 months
Metabolomic profiling as a function of maternal choline intake10-12 Weeks
Biomarkers for additional micronutrients10-12 Weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026