Biotin DeficiencyNCT00894920
Biotin Status in Pregnancy
A study testing biotin in people with Biotin Deficiency, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Biotin Deficiency
- What is being tested?
- biotin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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.
- Conditions
- Biotin Deficiency
- Being tested
- biotin
- Keywords
- biotin, deficiency, pregnancy, lymphocyte propionyl-CoA carboxylase
- Medical subject headings
- Biotin deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biotinDietary supplement
capsule approximately 30 mcg daily 21 days
biotinDietary supplement
capsule 300 mcg daily 21 days
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: biotin |
| biotin | Active comparator | Not described Receives: Dietary Supplement: biotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphocyte propionyl-CoA carboxylase (PCC) activities
Measured: 2-3 months
Secondary outcomes (3)
Urinary biotin excretion
Measured: 2-3 months
Urinary 3-hydroxyisovaleric acid (3HIA) excretion
Measured: 2-3 months
Other biotin-related indicators in urine and blood
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startAug 2009
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biotin DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald M Mock, MD,PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894920
- Sponsor's protocol ID
- 3114301
- Other IDs
- R01DK079892-01, 107068
- Status last verified
- Feb 2015
- First submitted
- 6 May 2009
- Last updated
- 2 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biotin Status in Pregnancy
- ClinicalTrials.gov ID
- NCT00894920
- Acronym / sponsor ID
- 3114301
- Conditions
- Biotin Deficiency
- Keywords
- biotin, deficiency, pregnancy, lymphocyte propionyl-CoA carboxylase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 7 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: biotin |
| biotin | Active comparator | Dietary Supplement: biotin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- prenatal vitamin with greater than 30 mcg biotin
- antibiotic use
- known renal disease
- drug, alcohol abuse
- gastric bypass
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biotincapsule approximately 30 mcg daily 21 days | Dietary supplement | placebo |
| biotincapsule 300 mcg daily 21 days | Dietary supplement | biotin |
Primary outcome
Lymphocyte propionyl-CoA carboxylase (PCC) activities
Time frame: 2-3 months
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
Related trials for Biotin Deficiency
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
RecruitingObservational study
Neonatal Screening of Biotinidase Deficiency: Genotype-phenotype Correlation and Clinical Follow-up
Biotinidase Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald M Mock, MD,PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biotin in people with Biotin Deficiency, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphocyte propionyl-CoA carboxylase (PCC) activities (time frame: 2-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2015.