Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Biotin Status in Pregnancy

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Arkansas Identifier:
First received: May 6, 2009
Last updated: February 21, 2014
Last verified: February 2014

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:

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 2014 (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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00894920

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

Additional Information:
No publications provided

Responsible Party: University of Arkansas Identifier: NCT00894920     History of Changes
Other Study ID Numbers: 3114301, RO1DK079892-01, 107068
Study First Received: May 6, 2009
Last Updated: February 21, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Vitamin B Complex
Vitamins processed this record on February 27, 2015