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

Phase 3

• Conditions: Malnutrition
• Interventions: 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

• Registration Number: NCT01917032
• Lead Sponsor: CES University

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-08
• Study First Submitted: 2013-08-02
• Study First Submitted QC: 2013-08-05
• Last Update Submitted: 2013-08-05
• Study First Posted: 2013-08-06
• Last Update Posted: 2013-08-06
• Study Start: 2013-09
• Primary Completion: 2013-11
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sprinkles	Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food	Micronutrient Powder Sprinkles 1 gram orally on weekdays during 11 weeks
Placebo	placebo	Maltodextrin 1 gram orally on weekdays during 11 weeks

Primary Outcome Measures

Name	Time	Method
Hemoglobin	10 weeks	Hemoglobin quantitation for laboratory tests (g/dl)

Secondary Outcome Measures

Name	Time	Method
Transferrin	10 weeks	Transferrin quantitation for laboratory tests (mg/dl)

Trial Locations

Locations (1)

Fundación de Atención a la Niñez (FAN); 🇨🇴 Medellín, Ant, Colombia