Overview

This trial is active, not recruiting.

Condition biotin deficiency
Treatments biotin
Sponsor University of Arkansas
Start date August 2009
End date August 2014
Trial size 104 participants
Trial identifier NCT00894920, 107068, 3114301, RO1DK079892-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Placebo Comparator)
biotin
capsule approximately 30 mcg daily 21 days
(Active Comparator)
biotin
capsule 300 mcg daily 21 days

Primary Outcomes

Measure
Lymphocyte propionyl-CoA carboxylase (PCC) activities
time frame: 2-3 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants from 18 years up to 40 years old.

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

Additional Information

Official title Biotin Status in Pregnancy
Principal investigator Donald M Mock, MD,PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by University of Arkansas.