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Biotin Status in Pregnancy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00894920
First received: May 6, 2009
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Biotin Deficiency
 Dietary Supplement: biotin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Biotin Status in Pregnancy

Resource links provided by NLM:

Drug Information available for: Biotin
U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Lymphocyte propionyl-CoA carboxylase (PCC) activities [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary biotin excretion [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]
  • Urinary 3-hydroxyisovaleric acid (3HIA) excretion [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]
  • Other biotin-related indicators in urine and blood [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: August 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Dietary Supplement: biotin
capsule approximately 30 mcg daily 21 days
Active Comparator: biotin Dietary Supplement: biotin
capsule 300 mcg daily 21 days

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894920

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Donald M Mock, MD,PhD University of Arkansas
  More Information

Additional Information:
Website for University of Arkansas for Medical Sciences  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00894920     History of Changes
Other Study ID Numbers: 3114301, RO1DK079892-01, 107068
Study First Received: May 6, 2009
Last Updated: January 31, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Arkansas:
biotin
deficiency
pregnancy
lymphocyte propionyl-CoA carboxylase

Additional relevant MeSH terms:
Biotinidase Deficiency
Multiple Carboxylase Deficiency
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Carbohydrate Metabolism, Inborn Errors
Metabolic Diseases
 Biotin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013