Biotin Status in Pregnancy
Not Applicable
Completed
- Conditions
- Biotin Deficiency
- Registration Number
- NCT00894920
- Lead Sponsor
- University of Arkansas
- Brief Summary
The purpose of this study is to estimate the number of pregnant women who, during pregnancy, have low levels of the vitamin biotin. The hypothesis of this study is that a large number of pregnant women will have low biotin levels. This information will be used to later determine if low biotin levels during pregnancy cause certain birth defects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 124
Inclusion Criteria
- age 18-40
- in early pregnancy (less than 15 weeks gestation)
- under care of physician
- normal pregnancy
- taking prenatal vitamin with less than 30 mcg biotin
Exclusion Criteria
- prenatal vitamin with greater than 30 mcg biotin
- antibiotic use
- known renal disease
- drug, alcohol abuse
- gastric bypass
- daily diet high in biotin
- use of certain meal replacement products high in biotin
- previous history of children with birth defects
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Lymphocyte propionyl-CoA carboxylase (PCC) activities 2-3 months
- Secondary Outcome Measures
Name Time Method Other biotin-related indicators in urine and blood 2-3 months Urinary 3-hydroxyisovaleric acid (3HIA) excretion 2-3 months Urinary biotin excretion 2-3 months
Trial Locations
- Locations (1)
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences🇺🇸Little Rock, Arkansas, United States