Clinical trial NCT01412411: Appropriate Complmentary Feeding Strategies in Infants
Official title: Appropriate Complementary Feeding Strategies in Infants: An Evaluation of Various Strategies to Assess the Growth and Health of the Infants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: Anemia
Growth
Infants
Focus of the study is to assess the level of anemia and growth indicators among the infants
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: European Union
First posted: 2011-08-09
Enrollment: 470
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Anemia
timeFrame: 12 months
Secondary outcomes:
measure: Compliance to intake of study medicines
timeFrame: 12 months
measure: Morbidity Assessment
timeFrame: 12 months
measure: Developmental Assessment
timeFrame: 12 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Bilal Colony Centre
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Aziz AJ Abdul Rehman Jiwani, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan University
name: Zulfiqar ZB Bhuta, MBBS, MCPS (Peds), FCPS (Peds)
role: STUDY_CHAIR
References: