Appropriate Complmentary Feeding Strategies in Infants (CFS)
|ClinicalTrials.gov Identifier: NCT01412411|
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : August 9, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Behavioral: Nutritionl Education Dietary Supplement: Oral Iron Supplementation along with Nturition Eductaion Dietary Supplement: Multiple micronutrient fortification plus Nutrition Education||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||470 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Appropriate Complementary Feeding Strategies in Infants: An Evaluation of Various Strategies to Assess the Growth and Health of the Infants.|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
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
|Dietary Supplement: Multiple micronutrient fortification plus Nutrition Education|
Active Comparator: OIS plus Nutritional Eductaion
In this group, along with the nutritional education, Oral Iron Supplementation was given.
|Dietary Supplement: Oral Iron Supplementation along with Nturition Eductaion|
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.
Behavioral: Nutritionl Education
to assess the change in behaviour
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412411
|Bilal Colony Centre|
|Karachi, Sindh, Pakistan, 74800|
|Principal Investigator:||Aziz AJ Abdul Rehman Jiwani, MBBS, PhD||The Aga Khan University|
|Study Chair:||Zulfiqar ZB Bhuta, MBBS, MCPS (Peds), FCPS (Peds)||The Aga Khan University|