Appropriate Complmentary Feeding Strategies in Infants

Appropriate Complementary Feeding Strategies in Infants: An Evaluation of Various Strategies to Assess the Growth and Health of the Infants.

Sponsors

Lead Sponsor: Aga Khan University

Collaborator: The Hospital for Sick Children
European Union

Source Aga Khan University
Brief Summary

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

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.

Overall Status Completed
Start Date October 2005
Completion Date June 2008
Primary Completion Date June 2008
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Anemia 12 months
Secondary Outcome
Measure Time Frame
Compliance to intake of study medicines 12 months
Morbidity Assessment 12 months
Developmental Assessment 12 months
Enrollment 470
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Nutritionl Education

Description: to assess the change in behaviour

Arm Group Label: Nutrition Education Group

Intervention Type: Dietary Supplement

Intervention Name: Oral Iron Supplementation along with Nturition Eductaion

Arm Group Label: OIS plus Nutritional Eductaion

Intervention Type: Dietary Supplement

Intervention Name: Multiple micronutrient fortification plus Nutrition Education

Arm Group Label: Nutrition Education plus Multiple Micronutrient Fortification

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 6 Months

Maximum Age: 8 Months

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Location
Facility: Bilal Colony Centre
Location Countries

Pakistan

Verification Date

March 2008

Responsible Party

Name Title: Dr Aziz Abdul Rehman Jiwani

Organization: The Aga Khan University

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Nutrition Education plus Multiple Micronutrient Fortification

Type: Active Comparator

Description: In this group along with the nutritional education, multiple micronutrient fortification was given in the form of Sprinkles

Label: OIS plus Nutritional Eductaion

Type: Active Comparator

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

Label: Nutrition Education Group

Type: Active Comparator

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

Acronym CFS
Study Design Info

Allocation: Randomized

Intervention Model: Factorial Assignment

Primary Purpose: Health Services Research

Masking: None (Open Label)

Source: ClinicalTrials.gov