Biotin Status in Pregnancy

Biotin Deficiency Clinical Trial

Official title:

Biotin Status in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894920
• Other study ID #: 3114301
• Secondary ID: RO1DK079892-0110
• Status: Completed
• Phase: N/A
• First received: May 6, 2009
• Last updated: February 26, 2015
• Start date: August 2009
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Biotin Deficiency
• Biotinidase Deficiency

Intervention

Dietary Supplement:
• biotin
capsule approximately 30 mcg daily 21 days
• biotin
capsule 300 mcg daily 21 days

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymphocyte propionyl-CoA carboxylase (PCC) activities		2-3 months	No
Secondary	Urinary biotin excretion		2-3 months	No
Secondary	Urinary 3-hydroxyisovaleric acid (3HIA) excretion		2-3 months	No
Secondary	Other biotin-related indicators in urine and blood		2-3 months	No

External Links

•   Website for University of Arkansas for Medical Sciences