Human Requirements for the Nutrient Choline
|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: NCT00065546|
Recruitment Status : Completed
First Posted : July 31, 2003
Last Update Posted : January 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Postmenopausal Women||Other: Estrogen plus choline depletion diet Other: Placebo plus choline depletion diet Other: Pre-menopausal women with SNPs given a low choline diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Human Requirements for the Nutrient Choline|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||January 2012|
Active Comparator: 1
Post-menopausal women randomized to receive estrogen replacement therapy.
Other: Estrogen plus choline depletion diet
Post-menopausal subjects receive estrogen and are then challenged with a low choline diet to determine if estrogen protects them from induction of choline deficiency.
Placebo Comparator: 2
Post-menopausal women randomized to receive a placebo.
Other: Placebo plus choline depletion diet
Post-menopausal women are randomized to receive a placebo and are then subjected to a low choline diet to determine if clinical signs of choline deficiency can be induced.
Pre-menopausal women with specific genetic variants.
Other: Pre-menopausal women with SNPs given a low choline diet
Pre-menopausal women with specific genetic polymorphisms in genes related to choline metabolism are placed on a choline depletion diet to determine if the SNPs increase or decrease the risk of diet-induced choline deficiency.
- Evidence of liver or muscle dysfunction (based on elevations in CPK, AST, ALT), or increased liver fat (measured by liver MRI) [ Time Frame: Labs measured every 3-4 days throughout 62-day trial. Liver MRI performed on study days 1, 10, 31, 52, 62. ]
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): NCT00065546
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Steven H Zeisel, MD, PhD||University of North Carolina, Chapel Hill|
|Study Director:||Leslie M Fischer, PhD, MPH, RD||University of North Carolina, Chapel Hill|