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Completed

NCT Number: NCT01412411

Appropriate Complmentary Feeding Strategies in Infants

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.

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Key information

Age range

6 month–8 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bilal Colony Centre

Karachi, Sindh, 74800, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritionl Education

Behavioral

to assess the change in behaviour

Oral Iron Supplementation along with Nturition Eductaion

Dietary Supplement

Multiple micronutrient fortification plus Nutrition Education

Dietary Supplement

Primary outcomes

  1. 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

Secondary outcomes

  1. Compliance to intake of study medicines

    Time frame: 12 months

    Compliance was checked to ensure that subjects are taking study medicines properly.

  2. Morbidity Assessment

    Time frame: 12 months

    Subjects were assessed on fortnighty basis to see any change in the morbidity.

  3. Developmental Assessment

    Time frame: 12 months

    Subjects were assessed on monthly developmental milestones among the three groups.

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • European Union
  • The Hospital for Sick Children

Registry information

Official study title

Appropriate Complementary Feeding Strategies in Infants: An Evaluation of Various Strategies to Assess the Growth and Health of the Infants.

Acronym: CFS

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Aug 9, 2011
Registry last updated
Aug 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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