Effect of Home-fortification With Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín
NCT ID: NCT01917032
Last Updated: 2013-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2013-09-30
2013-12-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Sprinkles
Micronutrient Powder Sprinkles 1 gram orally on weekdays during 11 weeks
Sachets 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
Placebo
Maltodextrin 1 gram orally on weekdays during 11 weeks
placebo
Interventions
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Sachets 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
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 5 to 59 months.
Exclusion Criteria
* 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.
5 Months
59 Months
ALL
Yes
Sponsors
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CES University
OTHER
Responsible Party
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Cristian Vargas G. MD
Student
Principal Investigators
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Cristian Vargas, MD
Role: PRINCIPAL_INVESTIGATOR
CES University
Juliana Orozco, Nutricionist
Role: PRINCIPAL_INVESTIGATOR
CES University
Juliana Sánchez, Dentist
Role: STUDY_CHAIR
CES University
Liliana Montoya, Epidemiology
Role: STUDY_DIRECTOR
CES University
Javier Chica, Veterinarian
Role: STUDY_CHAIR
CES University
Maylen Rojas, Epidemiology
Role: STUDY_CHAIR
CES University
Óscar Villada, MD
Role: STUDY_CHAIR
CES University
Alejandro Díaz, Pediatrist
Role: STUDY_CHAIR
CES University
Locations
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Fundación de Atención a la Niñez (FAN)
Medellín, Ant, Colombia
Countries
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Central Contacts
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Facility Contacts
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Viviana Ramírez, Nutricionist
Role: primary
Other Identifiers
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SPRINK001
Identifier Type: -
Identifier Source: org_study_id