NCT01412580

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

10.4 years

First QC Date

August 8, 2011

Last Update Submit

August 5, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • Children's Cognitive Development

    During 2011-2012 (1 year)

  • Children's Health

    BMI, Disease Incidence, Self-reported health

    During 2011-2012 (1 year)

  • Parental Postnatal Investment Behavior

    Outcomes on parental care: care, cognitive stimulation, within-household time and money allocation

    During 2011-2012 (1 year)

  • Educational Status

    School attendance, Student performance (at school), Test Performance

    During 2011-2012 (1 year)

Secondary Outcomes (1)

  • Parental Labor Force Participation

    During 2011-2012 (1 year)

Study Arms (1)

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

Other: observational follow-up

Interventions

observational follow-up

observational followup

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

MUHAS

Dar es Salaam, Tanzania

Location

MeSH Terms

Conditions

Folic Acid Deficiency

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Plamen Nikolov

    Harvard University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

August 8, 2011

First Posted

August 9, 2011

Study Start

April 1, 2002

Primary Completion

September 1, 2012

Study Completion

September 1, 2013

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations