Biotin Status in Pregnancy

University of Arkansas

Status: Completed

Conditions: Biotin Deficiency

Treatments: Dietary Supplement: biotin

Study type: Interventional

Funder types: Other

Identifiers

NCT00894920

R01DK079892-01 (U.S. NIH Grant/Contract)

107068

3114301

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Treatment:

Dietary Supplement: biotin

Dietary Supplement: biotin

biotin

Active Comparator group

Treatment:

Dietary Supplement: biotin

Dietary Supplement: biotin