Effect of Home-fortification With Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|