Effect of Home-fortification With Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín
Recruitment status was: Not yet recruiting
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).
|Malnutrition||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||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effect of Home-fortification With Micronutrient Powder Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín: a Randomized Clinical Trial.|
- Hemoglobin [ Time Frame: 10 weeks ]Hemoglobin quantitation for laboratory tests (g/dl)
- Transferrin [ Time Frame: 10 weeks ]Transferrin quantitation for laboratory tests (mg/dl)
- Child Growth Indicators [ Time Frame: 10 weeks ]Anthropometric measurements as indicators of child growth and nutritional status
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Sprinkles
Micronutrient Powder Sprinkles 1 gram orally on weekdays during 11 weeks
Dietary Supplement: 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 Comparator: Placebo
Maltodextrin 1 gram orally on weekdays during 11 weeks
|Dietary Supplement: placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01917032
|Contact: Cristian Vargas, MDfirstname.lastname@example.org|
|Contact: Juliana Orozco, Nutritionistemail@example.com|
|Fundación de Atención a la Niñez (FAN)||Recruiting|
|Medellín, Ant, Colombia, 0574|
|Contact: Viviana Ramírez, Nutricionist 5744480288 firstname.lastname@example.org|
|Principal Investigator:||Cristian Vargas, MD||CES University|
|Principal Investigator:||Juliana Orozco, Nutricionist||CES University|
|Study Chair:||Juliana Sánchez, Dentist||CES University|
|Study Director:||Liliana Montoya, Epidemiology||CES University|
|Study Chair:||Javier Chica, Veterinarian||CES University|
|Study Chair:||Maylen Rojas, Epidemiology||CES University|
|Study Chair:||Óscar Villada, MD||CES University|
|Study Chair:||Alejandro Díaz, Pediatrist||CES University|