Biotin Status in Pregnancy

NCT ID: NCT00894920

Last Updated: 2015-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Biotin Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

biotin

Intervention Type DIETARY_SUPPLEMENT

capsule approximately 30 mcg daily 21 days

biotin

Group Type ACTIVE_COMPARATOR

biotin

Intervention Type DIETARY_SUPPLEMENT

capsule 300 mcg daily 21 days

Interventions

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biotin

capsule approximately 30 mcg daily 21 days

Intervention Type DIETARY_SUPPLEMENT

biotin

capsule 300 mcg daily 21 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald M Mock, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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R01DK079892-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

107068

Identifier Type: -

Identifier Source: secondary_id

3114301

Identifier Type: -

Identifier Source: org_study_id

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