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Appropriate Complmentary Feeding Strategies in Infants (CFS)

This study has been completed.
Sponsor:
Collaborators:
The Hospital for Sick Children
European Union
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT01412411
First received: August 3, 2011
Last updated: August 8, 2011
Last verified: March 2008

August 3, 2011
August 8, 2011
October 2005
June 2008   (final data collection date for primary outcome measure)
Anemia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To assess the impact of supplementation and multiple micronutrient fortification in comparison to nutritional education strategy to assess the biochecmical and growth indicators
Same as current
Complete list of historical versions of study NCT01412411 on ClinicalTrials.gov Archive Site
  • Compliance to intake of study medicines [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Compliance was checked to ensure that subjects are taking study medicines properly.
  • Morbidity Assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Subjects were assessed on fortnighty basis to see any change in the morbidity.
  • Developmental Assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Subjects were assessed on monthly developmental milestones among the three groups.
Same as current
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Anemia
  • 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
  • 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
    Intervention: 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.
    Intervention: 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.
    Intervention: Behavioral: Nutritionl Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
470
June 2008
June 2008   (final data collection date for primary outcome measure)

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.
Both
6 Months to 8 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT01412411
480/Peds-ERC-05
Yes
Dr Aziz Abdul Rehman Jiwani, The Aga Khan University
Aga Khan University
  • The Hospital for Sick Children
  • European Union
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
Aga Khan University
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP