Appropriate Complmentary Feeding Strategies in Infants (CFS)
Primary Purpose
Anemia
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Nutritionl Education
Oral Iron Supplementation along with Nturition Eductaion
Multiple micronutrient fortification plus Nutrition Education
Sponsored by
About this trial
This is an interventional health services research trial for Anemia focused on measuring Anemia, Growth, Infants, Focus of the study is to assess the level of anemia and growth indicators among the infants
Eligibility 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.
Sites / Locations
- Bilal Colony Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Nutrition Education plus Multiple Micronutrient Fortification
OIS plus Nutritional Eductaion
Nutrition Education Group
Arm Description
In this group along with the nutritional education, multiple micronutrient fortification was given in the form of Sprinkles
In this group, along with the nutritional education, Oral Iron Supplementation was given.
This is group was followed for the growth of the child and was given Nutritional Education to children's mothers.
Outcomes
Primary Outcome Measures
Anemia
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
Compliance was checked to ensure that subjects are taking study medicines properly.
Morbidity Assessment
Subjects were assessed on fortnighty basis to see any change in the morbidity.
Developmental Assessment
Subjects were assessed on monthly developmental milestones among the three groups.
Full Information
NCT ID
NCT01412411
First Posted
August 3, 2011
Last Updated
August 8, 2011
Sponsor
Aga Khan University
Collaborators
The Hospital for Sick Children, European Union
1. Study Identification
Unique Protocol Identification Number
NCT01412411
Brief Title
Appropriate Complmentary Feeding Strategies in Infants
Acronym
CFS
Official Title
Appropriate Complementary Feeding Strategies in Infants: An Evaluation of Various Strategies to Assess the Growth and Health of the Infants.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Aga Khan University
Collaborators
The Hospital for Sick Children, European Union
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Anemia, Growth, Infants, Focus of the study is to assess the level of anemia and growth indicators among the infants
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
470 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutrition Education plus Multiple Micronutrient Fortification
Arm Type
Active Comparator
Arm Description
In this group along with the nutritional education, multiple micronutrient fortification was given in the form of Sprinkles
Arm Title
OIS plus Nutritional Eductaion
Arm Type
Active Comparator
Arm Description
In this group, along with the nutritional education, Oral Iron Supplementation was given.
Arm Title
Nutrition Education Group
Arm Type
Active Comparator
Arm Description
This is group was followed for the growth of the child and was given Nutritional Education to children's mothers.
Intervention Type
Behavioral
Intervention Name(s)
Nutritionl Education
Intervention Description
to assess the change in behaviour
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Iron Supplementation along with Nturition Eductaion
Intervention Type
Dietary Supplement
Intervention Name(s)
Multiple micronutrient fortification plus Nutrition Education
Primary Outcome Measure Information:
Title
Anemia
Description
To assess the impact of supplementation and multiple micronutrient fortification in comparison to nutritional education strategy to assess the biochecmical and growth indicators
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Compliance to intake of study medicines
Description
Compliance was checked to ensure that subjects are taking study medicines properly.
Time Frame
12 months
Title
Morbidity Assessment
Description
Subjects were assessed on fortnighty basis to see any change in the morbidity.
Time Frame
12 months
Title
Developmental Assessment
Description
Subjects were assessed on monthly developmental milestones among the three groups.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
8 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aziz AJ Abdul Rehman Jiwani, MBBS, PhD
Organizational Affiliation
The Aga Khan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zulfiqar ZB Bhuta, MBBS, MCPS (Peds), FCPS (Peds)
Organizational Affiliation
The Aga Khan University
Official's Role
Study Chair
Facility Information:
Facility Name
Bilal Colony Centre
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
12. IPD Sharing Statement
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Appropriate Complmentary Feeding Strategies in Infants
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