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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

In context

Lead sponsor

University of Arkansas is the lead sponsor of 399 studies on the registry; 38 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.

Browse University of Arkansas studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

06

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

07

Study locations

1 site
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2009, a primary completion of Feb 2015 and a completion of Feb 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2009
First posted
May 7, 2009
Start
Aug 2009
Primary completionActual
Feb 2015
CompletionActual
Feb 2015
Last update
Mar 2, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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 ↗

Not currently enrolling

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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Discussion

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