Biotin Status in Pregnancy

University of Arkansas124 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

124

Conditions

Biotin Deficiency

Interventions

biotinDIETARY_SUPPLEMENT

capsule approximately 30 mcg daily 21 days

biotinDIETARY_SUPPLEMENT

capsule 300 mcg daily 21 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Lymphocyte propionyl-CoA carboxylase (PCC) activities

Time frame: 2-3 months

Secondary Outcomes

Urinary biotin excretion

Time frame: 2-3 months

Urinary 3-hydroxyisovaleric acid (3HIA) excretion

Time frame: 2-3 months

Other biotin-related indicators in urine and blood

Time frame: 2-3 months

Data from ClinicalTrials.gov

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