CClinicalTrials.gg
CompletedNCT00894920Updated Mar 2, 2015

Biotin Status in Pregnancy

An interventional study of biotin and biotin in Biotin Deficiency, sponsored by University of Arkansas. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-02.

Sponsored by University of Arkansas · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Biotin Deficiency

Keywords

  • biotin
  • deficiency
  • pregnancy
  • lymphocyte propionyl-CoA carboxylase
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
124 participants (actual)

Study arms

  • Placebo comparator
    placebo

    Dietary Supplement: biotin

  • Active comparator
    biotin

    Dietary Supplement: biotin

Interventions

  • Dietary supplementbiotin

    capsule approximately 30 mcg daily 21 days

  • Dietary supplementbiotin

    capsule 300 mcg daily 21 days

05

What researchers measure

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

06

Study locations

1 site
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
07

Registry details

Key details

Study ID
NCT00894920
Lead sponsor
University of Arkansas
Responsible party
Sponsor
First posted
May 7, 2009
Start date
Aug 2009
Primary completion
Feb 2015
Completion
Feb 2015
Last update
Mar 2, 2015

Study contacts

Donald M Mock, MD,PhD
principal investigator · University of Arkansas

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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