Appropriate Complmentary Feeding Strategies in Infants (CFS)

Aga Khan University

Status: Completed

Conditions: Anemia

Treatments: Dietary Supplement: Multiple micronutrient fortification plus Nutrition Education; Behavioral: Nutritionl Education; Dietary Supplement: Oral Iron Supplementation along with Nturition Eductaion

Study type: Interventional

Funder types: Other

Identifiers

NCT01412411

480/Peds-ERC-05

Details and patient eligibility

About

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 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.

Enrollment: 470 patients

Sex: All

Ages: 6 to 8 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

470 participants in 3 patient groups

Nutrition Education plus Multiple Micronutrient Fortification

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Multiple micronutrient fortification plus Nutrition Education

OIS plus Nutritional Eductaion

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Oral Iron Supplementation along with Nturition Eductaion

Nutrition Education Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Nutritionl Education