Effect of Home-fortification With Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín

Study Overview
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Brief Summary
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Objective: To acquire the local scientific evidence, to evaluate the effects of micronutrient Sprinkles™ powder, both the nutritional status and haematological values in the vulnerable preschool population, to corroborate the reported benefits of the experiences in other countries. Question: Will it improve the nutritional status and hematological levels after the home fortification with Sprinkles in children of two child care centres in the city of Medellin, in 2013? Hypothesis: At the end of intervention, hematologic levels and anthropometric indicators will be better in the intervention group with Sprinkles, compared with the placebo group. Design: Randomized clinical trial, triple-blind and placebo-controlled. Participants: Two groups of 50 children each, aged between 5 and 59 months, not anemic or with severe malnourished, full-time assistants to two children's centres that have the same alimentation menu. Intervention: The daily diet will be supplemented with sprinkles in one of the children's centres and will be compared anthropometric and hematological values before and after with a group receiving the same diet with placebo. Outcome measures: Nutritional status (anthropometric measures) and haematological values (hemoglobin, ferritin, transferrin and folate).

Official Title
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Effect of Home-fortification With Micronutrient Powder Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín: a Randomized Clinical Trial.

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Assistance to children's centres full day (8 hours). Age 5 to 59 months. Exclusion Criteria: Anemia (hemoglobin less than 11 g / dl). Current supplementation with a product formulated by a health professional as a part of a nutritional recovery. Denial for informed consent signing by parents or legal guardians. Diagnosis of severe acute malnutrition by anthropometric measurements.

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sprinkles<br>Micronutrient Powder Sprinkles 1 gram orally on weekdays during 11 weeks | Dietary Supplement: Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food<br>* 1 g orally on weekdays during 11 weeks<br>* Other names: Sprinkles;|
| Placebo Comparator: Placebo<br>Maltodextrin 1 gram orally on weekdays during 11 weeks | Dietary Supplement: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin | Hemoglobin quantitation for laboratory tests (g/dl) | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transferrin | Transferrin quantitation for laboratory tests (mg/dl) | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trace Elements, Preschool, Malnutrition, Fortified Food