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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01412411
Acronym
CFS
Enrollment
470
Registered
2011-08-09
Start date
2005-10-31
Completion date
2008-06-30
Last updated
2011-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

Anemia, Growth, Infants, Focus of the study is to assess the level of anemia and growth indicators among the infants

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.

Interventions

BEHAVIORALNutritionl Education

to assess the change in behaviour

DIETARY_SUPPLEMENTOral Iron Supplementation along with Nturition Eductaion
DIETARY_SUPPLEMENTMultiple micronutrient fortification plus Nutrition Education

Sponsors

The Hospital for Sick Children
CollaboratorOTHER
European Union
CollaboratorOTHER
Aga Khan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 8 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Anemia12 monthsTo assess the impact of supplementation and multiple micronutrient fortification in comparison to nutritional education strategy to assess the biochecmical and growth indicators

Secondary

MeasureTime frameDescription
Compliance to intake of study medicines12 monthsCompliance was checked to ensure that subjects are taking study medicines properly.
Morbidity Assessment12 monthsSubjects were assessed on fortnighty basis to see any change in the morbidity.
Developmental Assessment12 monthsSubjects were assessed on monthly developmental milestones among the three groups.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026