Appropriate Complmentary Feeding Strategies in Infants

Anemia Clinical Trial

— CFS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412411
• Other study ID #: 480/Peds-ERC-05
• Status: Completed
• Phase: N/A
• First received: August 3, 2011
• Last updated: August 8, 2011
• Start date: October 2005
• Est. completion date: June 2008

Study information

• Verified date: March 2008
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: European Union
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 8 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Anemia

Intervention

Behavioral:
• Nutritionl Education
to assess the change in behaviour

Dietary Supplement:
• Oral Iron Supplementation along with Nturition Eductaion

• Multiple micronutrient fortification plus Nutrition Education

Locations

Country	Name	City	State
Pakistan	Bilal Colony Centre	Karachi	Sindh

Sponsors (3)

Lead Sponsor	Collaborator
Aga Khan University	European Union, The Hospital for Sick Children

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anemia	To assess the impact of supplementation and multiple micronutrient fortification in comparison to nutritional education strategy to assess the biochecmical and growth indicators	12 months	No
Secondary	Compliance to intake of study medicines	Compliance was checked to ensure that subjects are taking study medicines properly.	12 months	No
Secondary	Morbidity Assessment	Subjects were assessed on fortnighty basis to see any change in the morbidity.	12 months	No
Secondary	Developmental Assessment	Subjects were assessed on monthly developmental milestones among the three groups.	12 months	No