Appropriate Complmentary Feeding Strategies in Infants

Overview

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.

Full Title of Study: “Appropriate Complementary Feeding Strategies in Infants: An Evaluation of Various Strategies to Assess the Growth and Health of the Infants.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2008

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.

Interventions

  • Behavioral: Nutritionl Education
    • to assess the change in behaviour
  • Dietary Supplement: Oral Iron Supplementation along with Nturition Eductaion
  • Dietary Supplement: Multiple micronutrient fortification plus Nutrition Education

Arms, Groups and Cohorts

  • Active Comparator: Nutrition Education plus Multiple Micronutrient Fortification
    • In this group along with the nutritional education, multiple micronutrient fortification was given in the form of Sprinkles
  • Active Comparator: OIS plus Nutritional Eductaion
    • In this group, along with the nutritional education, Oral Iron Supplementation was given.
  • Active Comparator: Nutrition Education Group
    • This is group was followed for the growth of the child and was given Nutritional Education to children’s mothers.

Clinical Trial Outcome Measures

Primary Measures

  • Anemia
    • Time Frame: 12 months
    • To assess the impact of supplementation and multiple micronutrient fortification in comparison to nutritional education strategy to assess the biochecmical and growth indicators

Secondary Measures

  • Compliance to intake of study medicines
    • Time Frame: 12 months
    • Compliance was checked to ensure that subjects are taking study medicines properly.
  • Morbidity Assessment
    • Time Frame: 12 months
    • Subjects were assessed on fortnighty basis to see any change in the morbidity.
  • Developmental Assessment
    • Time Frame: 12 months
    • Subjects were assessed on monthly developmental milestones among the three groups.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 6 Months

Maximum Age: 8 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Aga Khan University
  • Collaborator
    • The Hospital for Sick Children
  • Provider of Information About this Clinical Study
    • Dr Aziz Abdul Rehman Jiwani, The Aga Khan University
  • Overall Official(s)
    • Aziz AJ Abdul Rehman Jiwani, MBBS, PhD, Principal Investigator, The Aga Khan University
    • Zulfiqar ZB Bhuta, MBBS, MCPS (Peds), FCPS (Peds), Study Chair, The Aga Khan University

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