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

CES University

Status and phase: Unknown; Phase 3

Conditions: Malnutrition

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT01917032

SPRINK001

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 5 to 59 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Sprinkles

Active Comparator group

Description:

Micronutrient Powder Sprinkles 1 gram orally on weekdays during 11 weeks

Treatment:

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

Placebo

Placebo Comparator group

Description:

Maltodextrin 1 gram orally on weekdays during 11 weeks

Treatment:

Dietary Supplement: placebo