NCT00894920

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 2, 2015

Status Verified

February 1, 2015

Enrollment Period

5.5 years

First QC Date

May 6, 2009

Last Update Submit

February 26, 2015

Conditions

Biotin Deficiency

Keywords

biotindeficiencypregnancylymphocyte propionyl-CoA carboxylase

Outcome Measures

Primary Outcomes (1)

  • Lymphocyte propionyl-CoA carboxylase (PCC) activities

    2-3 months

Secondary Outcomes (3)

  • Urinary biotin excretion

    2-3 months

  • Urinary 3-hydroxyisovaleric acid (3HIA) excretion

    2-3 months

  • Other biotin-related indicators in urine and blood

    2-3 months

Study Arms (2)

placebo

PLACEBO COMPARATOR
Dietary Supplement: biotin

biotin

ACTIVE COMPARATOR
Dietary Supplement: biotin

Interventions

biotinDIETARY_SUPPLEMENT

capsule approximately 30 mcg daily 21 days

placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Biotin deficiency

Interventions

Biotin

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCoenzymesEnzymes and Coenzymes

Study Officials

  • Donald M Mock, MD,PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2009

First Posted

May 7, 2009

Study Start

August 1, 2009

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 2, 2015

Record last verified: 2015-02

Locations

US(1)