Appropriate Complmentary Feeding Strategies in Infants

NCT ID: NCT01412411

Last Updated: 2011-08-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

470 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this study has been to understand the prevalence of under nutrition and develop effective interventions for improving growth and micronutrient status of infants receiving complementary foods.

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.

Detailed Description

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Transition from exclusive breast feeding to complementary feeding poses many challenges as the demand for nutrients necessary for optimum growth and development increases steadily. Malnutrition and micronutrient malnutrition can be inter-generational and affect pregnant mothers and consequently the baby may be born with deficient micronutrient stores, especially those of iron. This deficiency can be further exacerbated by sub-optimal practices of breast feeding. Globally, iron deficiency is the most common cause of anemia estimated to affect nearly 2 billion people especially preschool children. In Pakistan, 56 % of children under the age of five years are estimated to have iron deficiency anemia and 13 % are also severely malnourished. These deficiencies affect not only physical growth but also mental development with significant impact on immunity and increased burden of infections. It is uncertain what the most appropriate intervention strategy is and a wide range of options are mentioned including dietary diversification through nutrition education, provision of fortified foods, iron supplementation and home-based fortification of complementary foods with micronutrient powders such as Sprinkles.

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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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

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

Group Type ACTIVE_COMPARATOR

Multiple micronutrient fortification plus Nutrition Education

Intervention Type DIETARY_SUPPLEMENT

OIS plus Nutritional Eductaion

In this group, along with the nutritional education, Oral Iron Supplementation was given.

Group Type ACTIVE_COMPARATOR

Oral Iron Supplementation along with Nturition Eductaion

Intervention Type DIETARY_SUPPLEMENT

Nutrition Education Group

This is group was followed for the growth of the child and was given Nutritional Education to children's mothers.

Group Type ACTIVE_COMPARATOR

Nutritionl Education

Intervention Type BEHAVIORAL

to assess the change in behaviour

Interventions

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Nutritionl Education

to assess the change in behaviour

Intervention Type BEHAVIORAL

Oral Iron Supplementation along with Nturition Eductaion

Intervention Type DIETARY_SUPPLEMENT

Multiple micronutrient fortification plus Nutrition Education

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* All children between the age of 6 months to 8 months.

Exclusion Criteria

* Children who are sick to an extent that cannot take anythign oral were excluded from this study.
Minimum Eligible Age

6 Months

Maximum Eligible Age

8 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role collaborator

European Union

OTHER

Sponsor Role collaborator

Aga Khan University

OTHER

Sponsor Role lead

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

Site Status

Countries

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Pakistan

Other Identifiers

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480/Peds-ERC-05

Identifier Type: -

Identifier Source: org_study_id

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