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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
  Purpose

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 Intervention
Anemia
Behavioral: Nutritionl Education
Dietary Supplement: Oral Iron Supplementation along with Nturition Eductaion
Dietary Supplement: Multiple micronutrient fortification plus Nutrition Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 470
Study Start Date: October 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Months to 8 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412411

Locations
Pakistan
Bilal Colony Centre
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
The Hospital for Sick Children
European Union
Investigators
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
  More Information

No publications provided

Responsible Party: Dr Aziz Abdul Rehman Jiwani, The Aga Khan University
ClinicalTrials.gov Identifier: NCT01412411     History of Changes
Other Study ID Numbers: 480/Peds-ERC-05
Study First Received: August 3, 2011
Last Updated: August 8, 2011
Health Authority: Germany: European Union

Keywords provided by Aga Khan University:
Anemia
Growth
Infants
Focus of the study is to assess the level of anemia and growth indicators among the infants

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Micronutrients
Trace Elements
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014