Neural Tube Defects - Spina Bifida and AnencephalyNCT00207558
Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification
A study testing folic acid in people with Neural Tube Defects - Spina Bifida and Anencephaly, run by Centers for Disease Control and Prevention at 1 site in China.
Trial summary
The aim of this study is to examine whether the same total daily dosage of folic acid, when taken as a single daily dose or as multiple divided doses throughout the day, results in different blood folate and homocysteine levels at the conclusion of the study. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neural Tube Defects - Spina Bifida and Anencephaly
- What is being tested?
- folic acid
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- Start not givento not given
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- -women who have delivered a baby two to four years ago, whose child is still alive, who are not breast-feeding, who are not pregnant or planning to become pregnant within the next 9 months following enrollment, who are using an IUD for contraception, and who have not taken vitamin supplements during the past 3 months
Who cannot join
- -women who have not delivered a baby two to four years ago, whose child is deceased, who are breast-feeding, who are currently pregnant or planning to become pregnant within the next 9 months following enrollment, who are not using an IUD for contraception, and who have taken vitamin supplements during the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to examine whether the same total daily dosage of folic acid, when taken as a single daily dose or as multiple divided doses throughout the day, results in different blood folate and homocysteine levels at the conclusion of the study. Further, a comparison of blood folate and homocysteine levels among women taking daily low-dosage (100mcg) and standard- dosage (400mcg) folic acid with those of women taking daily or weekly high-dosage (4000mcg) folic acid will be conducted.
- Being tested
- folic acid
- Medical subject headings
- Anencephaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
folic acidDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neural Tube Defects - Spina Bifida and AnencephalyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,100 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Peking University, Ministry of Science and Technology of the People´s Republic of China, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207558
- Sponsor's protocol ID
- CDC-NCBDDD-3970
- Other IDs
- U11/CCU015587-04-1, U11/CCU015586-05
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 13 Jul 2006
- Results posted
- No
Publications
Chen MY, Rose CE, Qi YP, Williams JL, Yeung LF, Berry RJ, Hao L, Cannon MJ, Crider KS. Defining the plasma folate concentration associated with the red blood cell folate concentration threshold for optimal neural tube defects prevention: a population-based, randomized trial of folic acid supplementation. Am J Clin Nutr. 2019 May 1;109(5):1452-1461. doi: 10.1093/ajcn/nqz027.
PubMed 31005964Crider KS, Zhu JH, Hao L, Yang QH, Yang TP, Gindler J, Maneval DR, Quinlivan EP, Li Z, Bailey LB, Berry RJ. MTHFR 677C->T genotype is associated with folate and homocysteine concentrations in a large, population-based, double-blind trial of folic acid supplementation. Am J Clin Nutr. 2011 Jun;93(6):1365-72. doi: 10.3945/ajcn.110.004671. Epub 2011 Apr 20.
PubMed 21508090
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification
- ClinicalTrials.gov ID
- NCT00207558
- Acronym / sponsor ID
- CDC-NCBDDD-3970
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Peking University, Ministry of Science and Technology of the People´s Republic of China, University of Florida
- First posted
- 21 Sep 2005 (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 aim of this study is to examine whether the same total daily dosage of folic acid, when taken as a single daily dose or as multiple divided doses throughout the day, results in different blood folate and homocysteine levels at the conclusion of the study. Further, a comparison of blood folate and homocysteine levels among women taking daily low-dosage (100mcg) and standard- dosage (400mcg) folic acid with those of women taking daily or weekly high-dosage (4000mcg) folic acid will be conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -women who have delivered a baby two to four years ago, whose child is still alive, who are not breast-feeding, who are not pregnant or planning to become pregnant within the next 9 months following enrollment, who are using an IUD for contraception, and who have not taken vitamin supplements during the past 3 months
Key exclusion criteria (1 listed)
- -women who have not delivered a baby two to four years ago, whose child is deceased, who are breast-feeding, who are currently pregnant or planning to become pregnant within the next 9 months following enrollment, who are not using an IUD for contraception, and who have taken vitamin supplements during the past 3 months
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 |
|---|---|---|
| folic acid | Drug | – |
Primary outcome
Not reported in the source record.
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 13 Jul 2006.
- Derived from this study: PubMed 31005964Chen MY, Rose CE, Qi YP, Williams JL, Yeung LF, Berry RJ, Hao L, Cannon MJ, Crider KS. Defining the plasma folate concentration associated with the red blood cell folate concentration threshold for optimal neural tube defects prevention: a population-based, randomized trial of folic acid supplementation. Am J Clin Nutr. 2019 May 1;109(5):1452-1461. doi: 10.1093/ajcn/nqz027.
- Derived from this study: PubMed 21508090Crider KS, Zhu JH, Hao L, Yang QH, Yang TP, Gindler J, Maneval DR, Quinlivan EP, Li Z, Bailey LB, Berry RJ. MTHFR 677C->T genotype is associated with folate and homocysteine concentrations in a large, population-based, double-blind trial of folic acid supplementation. Am J Clin Nutr. 2011 Jun;93(6):1365-72. doi: 10.3945/ajcn.110.004671. Epub 2011 Apr 20.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing folic acid in people with Neural Tube Defects - Spina Bifida and Anencephaly, run by Centers for Disease Control and Prevention at 1 site in China.
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 1 inclusion and 1 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 13 Jul 2006. 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 China. 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. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00207558, which also lists 2 linked publications.
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 13 Jul 2006.