Clinical trial NCT01917032: Effect of Home-fortification With Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín
Official title: Effect of Home-fortification With Micronutrient Powder Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Malnutrition
Keywords: Trace Elements
Preschool
Malnutrition
Fortified Food
Lead sponsor: CES University
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin
timeFrame: 10 weeks
Secondary outcomes:
measure: Transferrin
timeFrame: 10 weeks
Other outcomes:
measure: Child Growth Indicators
timeFrame: 10 weeks
Locations:
city: Medellín
country: Colombia
facility: Fundación de Atención a la Niñez (FAN)
state: Ant
Study officials:
affiliation: CES University
name: Cristian Vargas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CES University
name: Juliana Orozco, Nutricionist
role: PRINCIPAL_INVESTIGATOR
affiliation: CES University
name: Juliana Sánchez, Dentist
role: STUDY_CHAIR
affiliation: CES University
name: Liliana Montoya, Epidemiology
role: STUDY_DIRECTOR
affiliation: CES University
name: Javier Chica, Veterinarian
role: STUDY_CHAIR
affiliation: CES University
name: Maylen Rojas, Epidemiology
role: STUDY_CHAIR
affiliation: CES University
name: Óscar Villada, MD
role: STUDY_CHAIR
affiliation: CES University
name: Alejandro Díaz, Pediatrist
role: STUDY_CHAIR
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