Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
470 participants
INTERVENTIONAL
2005-10-31
2008-06-30
Brief Summary
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In this community based randomized clinical trial, the nutrition education package implemented aimed to improve hematological parameters including the micronutrient status and to see effect on growth indicators.
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Detailed Description
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In an effort to understand the prevalence of under nutrition and develop effective interventions for improving growth and micronutrient status of infants receiving complementary foods, I undertook a prospective community-based randomized controlled efficacy trial in a representative urban population of Karachi. Infants and mothers were identified after birth and enrolled in the study to receive one of the interventions through community health workers at the age of six months. The enrolled infants were placed in three groups - defined as Nutr Education (Nutr Edu), Oral iron supplementation (OIS) and Multiple micronutrient fortification (MMF). Nutrition education component was common to all the groups. Through nutritional education sessions held in the community, dietary diversification along with continuation of breast feeding was stressed to enhance the intake of diet, rich in iron, and other micronutrients. A cohort of 451 infants (177 in group Nutr Edu, 141 in group OIS and 133 in MMF) were followed for three months (till the end of treatments) for growth, micronutrient status, and morbidity rate and thereafter followed for another three months to evaluate anthropometric parameters.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Nutrition Education plus Multiple Micronutrient Fortification
In this group along with the nutritional education, multiple micronutrient fortification was given in the form of Sprinkles
Multiple micronutrient fortification plus Nutrition Education
OIS plus Nutritional Eductaion
In this group, along with the nutritional education, Oral Iron Supplementation was given.
Oral Iron Supplementation along with Nturition Eductaion
Nutrition Education Group
This is group was followed for the growth of the child and was given Nutritional Education to children's mothers.
Nutritionl Education
to assess the change in behaviour
Interventions
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Nutritionl Education
to assess the change in behaviour
Oral Iron Supplementation along with Nturition Eductaion
Multiple micronutrient fortification plus Nutrition Education
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Months
8 Months
ALL
Yes
Sponsors
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The Hospital for Sick Children
OTHER
European Union
OTHER
Aga Khan University
OTHER
Responsible Party
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The Aga Khan University
Principal Investigators
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Aziz AJ Abdul Rehman Jiwani, MBBS, PhD
Role: PRINCIPAL_INVESTIGATOR
Aga Khan University
Zulfiqar ZB Bhuta, MBBS, MCPS (Peds), FCPS (Peds)
Role: STUDY_CHAIR
Aga Khan University
Locations
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Bilal Colony Centre
Karachi, Sindh, Pakistan
Countries
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Other Identifiers
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480/Peds-ERC-05
Identifier Type: -
Identifier Source: org_study_id
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