Effect of Home-fortification With Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín
|ClinicalTrials.gov Identifier: NCT01917032|
Recruitment Status : Unknown
Verified August 2013 by Cristian Vargas G. MD, CES University.
Recruitment status was: Not yet recruiting
First Posted : August 6, 2013
Last Update Posted : August 6, 2013
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).
|Condition or disease||Intervention/treatment||Phase|
|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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||September 2013|
|Estimated Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||December 2013|
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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917032
|Contact: Cristian Vargas, MDemail@example.com|
|Contact: Juliana Orozco, Nutritionistfirstname.lastname@example.org|
|Fundación de Atención a la Niñez (FAN)||Recruiting|
|Medellín, Ant, Colombia, 0574|
|Contact: Viviana Ramírez, Nutricionist 5744480288 email@example.com|
|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|