Malnutrition
Conditions
Keywords
Trace Elements, Preschool, Malnutrition, Fortified Food
Brief summary
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).
Interventions
DIETARY_SUPPLEMENTSachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food
1 g orally on weekdays during 11 weeks
DIETARY_SUPPLEMENTplacebo
Sponsors
CES University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Months to 59 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin | 10 weeks | Hemoglobin quantitation for laboratory tests (g/dl) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transferrin | 10 weeks | Transferrin quantitation for laboratory tests (mg/dl) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Child Growth Indicators | 10 weeks | Anthropometric measurements as indicators of child growth and nutritional status |
Countries
Colombia
Contacts
Primary ContactCristian Vargas, MD
Backup ContactJuliana Orozco, Nutritionist
Outcome results
None listed