Trials / Completed
CompletedNCT01412411
Appropriate Complmentary Feeding Strategies in Infants
Appropriate Complementary Feeding Strategies in Infants: An Evaluation of Various Strategies to Assess the Growth and Health of the Infants.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 470 (actual)
- Sponsor
- Aga Khan University · Academic / Other
- Sex
- All
- Age
- 6 Months – 8 Months
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2008-06-01
- Completion
- 2008-06-01
- First posted
- 2011-08-09
- Last updated
- 2011-08-09
Locations
1 site across 1 country: Pakistan
Source: ClinicalTrials.gov record NCT01412411. Inclusion in this directory is not an endorsement.