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| Name | Class |
|---|---|
| The Hospital for Sick Children | OTHER |
| European Union | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition Education plus Multiple Micronutrient Fortification | Active Comparator | In this group along with the nutritional education, multiple micronutrient fortification was given in the form of Sprinkles |
|
| OIS plus Nutritional Eductaion | Active Comparator | In this group, along with the nutritional education, Oral Iron Supplementation was given. |
|
| Nutrition Education Group | Active Comparator | This is group was followed for the growth of the child and was given Nutritional Education to children's mothers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritionl Education | Behavioral | to assess the change in behaviour |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Anemia | To assess the impact of supplementation and multiple micronutrient fortification in comparison to nutritional education strategy to assess the biochecmical and growth indicators | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance to intake of study medicines | Compliance was checked to ensure that subjects are taking study medicines properly. | 12 months |
| Morbidity Assessment | Subjects were assessed on fortnighty basis to see any change in the morbidity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aziz AJ Abdul Rehman Jiwani, MBBS, PhD | Aga Khan University | Principal Investigator |
| Zulfiqar ZB Bhuta, MBBS, MCPS (Peds), FCPS (Peds) | Aga Khan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bilal Colony Centre | Karachi | Sindh | 74800 | Pakistan |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Oral Iron Supplementation along with Nturition Eductaion |
| Dietary Supplement |
|
| Multiple micronutrient fortification plus Nutrition Education | Dietary Supplement |
|
| 12 months |
| Developmental Assessment | Subjects were assessed on monthly developmental milestones among the three groups. | 12 months |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |