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The Contribution of Health in Utero to Capacity Formation, Education and Economic Outcomes: Experimental Evidence From Tanzania (CDS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by:
Harvard University
ClinicalTrials.gov Identifier:
NCT01412580
First received: August 8, 2011
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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 folic acid, brain development in utero can biologically constrain children's demand for education. Using a more scientifically credible research design than has been used in previous research, the investigators examine how reductions in micronutrient deficiency (specifically for folic acid, B6, and B12) in utero affect subsequent child schooling attainment in Tanzania. The investigators also look at the extent to which parents allocate resources to compensate for or to reinforce inequalities in children's cognitive endowments. To execute this strategy, the investigators follow up on a Randomized Controlled Trial (RCT) with micronutrient supplements offered to HIV-negative pregnant women in Dar es Salaam, Tanzania, between 2001 to 2003.


Condition Intervention Phase
We Focus on the Effect of Folic Acid on Cognitive Development, Educational Outcomes and Parental Behavior.
 Drug: Folic Acid
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Contribution of Health in Utero to Capacity Formation, Education and Economic Outcomes: Experimental Evidence From Tanzania

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

Further study details as provided by Harvard University:

Primary Outcome Measures:
  • Children's Cognitive Development [ Time Frame: During 2011-2012 (1 year) ] [ Designated as safety issue: No ]
  • Children's Health [ Time Frame: During 2011-2012 (1 year) ] [ Designated as safety issue: Yes ]
    BMI, Disease Incidence, Self-reported health

  • Parental Postnatal Investment Behavior [ Time Frame: During 2011-2012 (1 year) ] [ Designated as safety issue: No ]
    Outcomes on parental care: care, cognitive stimulation, within-household time and money allocation

  • Educational Status [ Time Frame: During 2011-2012 (1 year) ] [ Designated as safety issue: No ]
    School attendance, Student performance (at school), Test Performance


Secondary Outcome Measures:
  • Parental Labor Force Participation [ Time Frame: During 2011-2012 (1 year) ] [ Designated as safety issue: No ]
    Parent's labor force outcomes: labor status, wages, type of job


Estimated Enrollment: 1200
Study Start Date: April 2002
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Folic Acid
Pill, 0.6mg given in 2002-2004, duration of pregnancy
Experimental: Folic Acid pill
Pill with B9, B6, B12
 Drug: Folic Acid
Pill, 0.6mg given in 2002-2004, duration of pregnancy

Detailed Description:

Previous research estimates microeconomic returns to education as high as 42 percent per annum in Botswana (for primary education) and 47.6 percent per annum in Zimbabwe (for secondary education). These large returns have stimulated a concerted effort in investing in education to stimulate growth. This project focuses on a mechanism that affects educational attainment through in utero nutritional environment.

While most micronutrient deficiencies can be resolved through improvements in economic outcomes by increasing caloric intake, deficiency in utero for four nutrients in particular (B6, B9, B12, and iodine) has been biologically linked to irreversible and continuous damage to a person's lifetime cognitive development.

In Tanzania, as in other sub-Saharan African countries, the dietary intake of nutrients by pregnant women is marginal or lower than recommended and therefore these women are at high risk for deficiencies. However, unlike general nutrition shortages in utero that can lead to lower educational attainment, increased rates of physical disability, lower income and lower socioeconomic status, fetal deficiency in B6, B12, and B9 (folic acid) permanently limits intellectual ability. Thus, the impact of this particular deficiency is likely to be particularly acute and persistent throughout a person's lifetime.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant women

Exclusion Criteria:

  • non-pregnant women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412580

Locations
Tanzania
MUHAS
Dar es Salaam, Tanzania
Sponsors and Collaborators
Harvard University
Muhimbili University of Health and Allied Sciences
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Plamen Nikolov, Harvard University
ClinicalTrials.gov Identifier: NCT01412580     History of Changes
Other Study ID Numbers: F19899-101
Study First Received: August 8, 2011
Last Updated: August 8, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
 Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013