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OpenTrials
Completed

NCT Number: NCT00894920

Biotin Status in Pregnancy

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.

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Key information

Conditions

Biotin Deficiency

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biotin

Dietary Supplement

capsule approximately 30 mcg daily 21 days

Primary outcomes

  1. Lymphocyte propionyl-CoA carboxylase (PCC) activities

    Time frame: 2-3 months

Secondary outcomes

  1. Urinary biotin excretion

    Time frame: 2-3 months

  2. Urinary 3-hydroxyisovaleric acid (3HIA) excretion

    Time frame: 2-3 months

  3. Other biotin-related indicators in urine and blood

    Time frame: 2-3 months

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
May 7, 2009
Registry last updated
Mar 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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