Appropriate Complmentary Feeding Strategies in Infants (CFS)
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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. |
- 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
- 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 |
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| Pakistan | |
| Bilal Colony Centre | |
| Karachi, Sindh, Pakistan, 74800 | |
| 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 Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013