Folic Acid DeficiencyCDSNCT01412580
In Utero Capacity Formation and Socio-economic Outcomes
An observational study of Folic Acid Deficiency, run by Harvard University at 1 site in Tanzania.
Trial summary
Because of the high returns of schooling in developing countries, policymakers pay a lot of attention to increasing school access. But if the mother is deficient in key micronutrients, brain development can biologically constrain children's demand for education. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Folic Acid Deficiency
- What is being tested?
- observational follow-up
- How many people
- 4,000 participants
- Where
- 1 siteTanzania
- Study dates
- Apr 2002to Sep 2013
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals from a larger study and this study is an observational follow-up.
These were individuals from the larger study and this study is an observational follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Contribution of Health in Utero to Capacity Formation, Education and Economic Outcomes: Experimental Evidence From Tanzania
Because of the high returns of schooling in developing countries, policymakers pay a lot of attention to increasing school access. But if the mother is deficient in key micronutrients, brain development can biologically constrain children's demand for education. To execute this strategy, the investigators collect cohort observational data on a previous randomized controlled trial with micronutrient supplements offered to HIV-negative pregnant women in Dar es Salaam, Tanzania, between 2001 to 2003.
Read the detailed description
This is a cohort study which collected follow-up observational data on households which were offered micronutrient supplements. The followup study outcomes include various socio-economic household characteristics and parental post-natal behaviors.
- Conditions
- Folic Acid Deficiency
- Being tested
- observational follow-up
- Medical subject headings
- Folic Acid Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational follow-upOther
observational follow-up
| Study group | Role | What they receive |
|---|---|---|
| observational followup | This was an observational follow-up to a larger study in which treatment group was given 20 mg of vitamin B1, 20 mg of vitamin B2, 25 mg of vitamin B6, 100 mg of niacin, 50 μg of vitamin B12, 500 mg of vitamin C, 30 mg of vitamin E, and 0.8 mg of folic acid Receives: Other: observational follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Cognitive Development
Measured: During 2011-2012 (1 year)
Children's Health
BMI, Disease Incidence, Self-reported health
Measured: During 2011-2012 (1 year)
Parental Postnatal Investment Behavior
Outcomes on parental care: care, cognitive stimulation, within-household time and money allocation
Measured: During 2011-2012 (1 year)
Educational Status
School attendance, Student performance (at school), Test Performance
Measured: During 2011-2012 (1 year)
Secondary outcomes (1)
Parental Labor Force Participation
Parent's labor force outcomes: labor status, wages, type of job
Measured: During 2011-2012 (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startApr 2002
- Primary completionSep 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Folic Acid 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
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Plamen Nikolov, Harvard University
- Investigators
- Plamen Nikolov, Study director, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412580
- Sponsor's protocol ID
- F19899-101
- Acronym
- CDS
- Status last verified
- Aug 2019
- First submitted
- 8 Aug 2011
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Health in Utero to Capacity Formation, Education and Economic Outcomes: Experimental Evidence From Tanzania
- ClinicalTrials.gov ID
- NCT01412580
- Acronym / sponsor ID
- CDS / F19899-101
- Conditions
- Folic Acid Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Study start
- Apr 2002
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 9 Aug 2011 (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.
Because of the high returns of schooling in developing countries, policymakers pay a lot of attention to increasing school access. But if the mother is deficient in key micronutrients, brain development can biologically constrain children's demand for education. To execute this strategy, the investigators collect cohort observational data on a previous randomized controlled trial with micronutrient supplements offered to HIV-negative pregnant women in Dar es Salaam, Tanzania, between 2001 to 2003.
Detailed description
This is a cohort study which collected follow-up observational data on households which were offered micronutrient supplements. The followup study outcomes include various socio-economic household characteristics and parental post-natal behaviors.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational followup | – | Other: observational follow-upThis was an observational follow-up to a larger study in which treatment group was given 20 mg of vitamin B1, 20 mg of vitamin B2, 25 mg of vitamin B6, 100 mg of niacin, 50 μg of vitamin B12, 500 mg of vitamin C, 30 mg of vitamin E, and 0.8 mg of folic acid |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals from a larger study and this study is an observational follow-up.
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 |
|---|---|---|
| observational follow-upobservational follow-up | Other | observational followup |
Primary outcome
Children's Cognitive Development
Time frame: During 2011-2012 (1 year)
Children's Health
Time frame: During 2011-2012 (1 year)
BMI, Disease Incidence, Self-reported health
Parental Postnatal Investment Behavior
Time frame: During 2011-2012 (1 year)
Outcomes on parental care: care, cognitive stimulation, within-household time and money allocation
Educational Status
Time frame: During 2011-2012 (1 year)
School attendance, Student performance (at school), Test Performance
1 secondary outcome
Parental Labor Force Participation
Time frame: During 2011-2012 (1 year)
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 7 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Plamen Nikolov study director
Harvard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Folic Acid Deficiency, run by Harvard University at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Aug 2019. 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 Tanzania. 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.
What does the primary outcome measure?
Children's Cognitive Development (time frame: During 2011-2012 (1 year)). The study lists 4 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 7 Aug 2019.