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Biotin Status in Pregnancy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00894920
First Posted: May 7, 2009
Last Update Posted: March 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Arkansas
  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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Biotin Status in Pregnancy

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Lymphocyte propionyl-CoA carboxylase (PCC) activities [ Time Frame: 2-3 months ]

Secondary Outcome Measures:
  • Urinary biotin excretion [ Time Frame: 2-3 months ]
  • Urinary 3-hydroxyisovaleric acid (3HIA) excretion [ Time Frame: 2-3 months ]
  • Other biotin-related indicators in urine and blood [ Time Frame: 2-3 months ]

Enrollment: 124
Study Start Date: August 2009
Study Completion Date: February 2015
Primary Completion Date: February 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00894920     History of Changes
Other Study ID Numbers: 3114301
R01DK079892-01 ( U.S. NIH Grant/Contract )
107068
First Submitted: May 6, 2009
First Posted: May 7, 2009
Last Update Posted: March 2, 2015
Last Verified: February 2015

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