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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pregnancy Lactation | Dietary Supplement: choline chloride Dietary Supplement: Choline Chloride | Not Applicable |
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 |

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. |
- Maternal biomarkers of choline status [ Time Frame: 10-12 Weeks ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts 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

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
United States, New York | |
Human Metabolic Research Unit, Cornell University | |
Ithaca, New York, United States, 14853 |
Principal Investigator: | Marie A Caudill, PhD, RD | Cornell University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Pregnancy Lactation Choline Cognition Biomarkers |
Choline Lipotropic Agents Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents Lipid Regulating Agents Nootropic Agents |