Neural Tube DefectsNCT00394862
Efficacy of Weekly Versus Daily Folic Acid Supplementation
A study testing multivitamin in people with Neural Tube Defects, run by Emory University.
Trial summary
Investigate the efficacy of weekly versus daily of folic acid supplementation on improving folate, vitamin B12, Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neural Tube Defects
- What is being tested?
- multivitamin
- How many people
- 460 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jul 2006
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- female
- aged 15-49
Who cannot join
- pregnant
- lactating less than 3 months
- severely anemic
About this study
Investigate the efficacy of weekly versus daily of folic acid supplementation on improving folate, vitamin B12,
Read the detailed description
460 women of a rural community in the western highlands of Guatemala were recruited for participation in the double-blinded study led by Emory University and the Institute of Nutrition of Central America and Panama (INCAP). The women were randomly assigned one of 4 vitamin treatments containing different levels of folic acid, Vitamin B12, iron and zinc. The treatments were as follows:
- weekly dose of folic acid at 5000ug, iron at 120 mg, zinc at 30mg, and B12 at 16.8 ug;
- weekly dose of folic acid at 2800ug, iron at 120mg, zinc at 0mg and B12 at 16.8ug;
- daily dose of folic acid at 400ug, iron at 60mg, zinc at 15mg, B12 at 2.4ug; and
- daily dose of folic acid at 200ug, iron at 50mg, zinc at 0mg, and B12 at 2.4ug.
The women, aged 15-49, received the vitamins daily for 3 months. Anthropometric data and blood samples were taken at baseline and post-supplementation. The participants also completed a series of dietary interviews at baseline and post-intervention. No pregnant or lactating mothers were admitted into the study, nor severely anemic females. Blood samples were sent to the National Laboratory in Cuernavaca, Mexico, for analysis of serum folate levels.
- Conditions
- Neural Tube Defects
- Being tested
- multivitamin
- Medical subject headings
- Neural Tube Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multivitaminDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
serum folate level
red blood cell folate
Secondary outcomes (6)
homocysteine
ferritin
serum zinc
serum B12
blood pressure
depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study startJan 2006
- Primary completionJun 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neural Tube DefectsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 460 participants
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Dr. Reynaldo Martorell, Emory University
- Investigators
- Reynaldo Martorell, PHD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394862
- Sponsor's protocol ID
- 205-2004
- Status last verified
- Mar 2012
- First submitted
- 31 Oct 2006
- Last updated
- 2 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Weekly Versus Daily Folic Acid Supplementation
- ClinicalTrials.gov ID
- NCT00394862
- Acronym / sponsor ID
- 205-2004
- Conditions
- Neural Tube Defects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Jan 2006
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 1 Nov 2006 (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.
Investigate the efficacy of weekly versus daily of folic acid supplementation on improving folate, vitamin B12,
Detailed description
460 women of a rural community in the western highlands of Guatemala were recruited for participation in the double-blinded study led by Emory University and the Institute of Nutrition of Central America and Panama (INCAP). The women were randomly assigned one of 4 vitamin treatments containing different levels of folic acid, Vitamin B12, iron and zinc. The treatments were as follows:
- weekly dose of folic acid at 5000ug, iron at 120 mg, zinc at 30mg, and B12 at 16.8 ug;
- weekly dose of folic acid at 2800ug, iron at 120mg, zinc at 0mg and B12 at 16.8ug;
- daily dose of folic acid at 400ug, iron at 60mg, zinc at 15mg, B12 at 2.4ug; and
- daily dose of folic acid at 200ug, iron at 50mg, zinc at 0mg, and B12 at 2.4ug.
The women, aged 15-49, received the vitamins daily for 3 months. Anthropometric data and blood samples were taken at baseline and post-supplementation. The participants also completed a series of dietary interviews at baseline and post-intervention. No pregnant or lactating mothers were admitted into the study, nor severely anemic females. Blood samples were sent to the National Laboratory in Cuernavaca, Mexico, for analysis of serum folate levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- female
- aged 15-49
Key exclusion criteria (3 listed)
- pregnant
- lactating less than 3 months
- severely anemic
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 |
|---|---|---|
| multivitamin | Drug | – |
Primary outcome
serum folate level
red blood cell folate
6 secondary outcomes
homocysteine
ferritin
serum zinc
serum B12
blood pressure
depression
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 Apr 2012.
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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.
Reynaldo Martorell, PHD, MPH principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
A study testing multivitamin in people with Neural Tube Defects, run by Emory University.
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 2 inclusion and 3 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 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
serum folate level. The study lists 2 primary outcomes in all. 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 Apr 2012.