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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sprinkles | Active Comparator | Micronutrient Powder Sprinkles 1 gram orally on weekdays during 11 weeks |
|
| Placebo | Placebo Comparator | Maltodextrin 1 gram orally on weekdays during 11 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food | Dietary Supplement | 1 g orally on weekdays during 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin | Hemoglobin quantitation for laboratory tests (g/dl) | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Transferrin | Transferrin quantitation for laboratory tests (mg/dl) | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Child Growth Indicators | Anthropometric measurements as indicators of child growth and nutritional status | 10 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristian Vargas, MD | Contact | 573006099044 | crivargas24@hotmail.com | |
| Juliana Orozco, Nutritionist | Contact | 573205371487 | julianaorozcocano@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Cristian Vargas, MD | CES University | Principal Investigator |
| Juliana Orozco, Nutricionist | CES University | Principal Investigator |
| Juliana Sánchez, Dentist |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación de Atención a la Niñez (FAN) | Medellín | Ant | 0574 | Colombia |
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|
| placebo | Dietary Supplement |
|
| CES University |
| Study Chair |
| Liliana Montoya, Epidemiology | CES University | Study Director |
| 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 | Study Chair |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007501 | Iron |
| D015032 | Zinc |
| D005492 | Folic Acid |
| D014801 | Vitamin A |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
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