Biotin Deficiency
Conditions
Keywords
biotin, deficiency, pregnancy, lymphocyte propionyl-CoA carboxylase
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.
Interventions
DIETARY_SUPPLEMENTbiotin
capsule approximately 30 mcg daily 21 days
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lymphocyte propionyl-CoA carboxylase (PCC) activities | 2-3 months |
Secondary
| Measure | Time frame |
|---|---|
| Urinary biotin excretion | 2-3 months |
| Urinary 3-hydroxyisovaleric acid (3HIA) excretion | 2-3 months |
| Other biotin-related indicators in urine and blood | 2-3 months |
Countries
United States
Outcome results
None listed