Human Requirements for the Nutrient Choline
|ClinicalTrials.gov Identifier: NCT00065546|
Recruitment Status : Completed
First Posted : July 31, 2003
Last Update Posted : January 6, 2012
|Condition or disease||Intervention/treatment|
|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|
|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|
|Primary Completion Date :||September 2009|
|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. ]
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|