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Effect of Home-fortification With Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Cristian Vargas G. MD, CES University.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Cristian Vargas G. MD, CES University Identifier:
First received: August 2, 2013
Last updated: August 5, 2013
Last verified: August 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 Intervention Phase
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
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.

Resource links provided by NLM:

Further study details as provided by Cristian Vargas G. MD, CES University:

Primary Outcome Measures:
  • Hemoglobin [ Time Frame: 10 weeks ]
    Hemoglobin quantitation for laboratory tests (g/dl)

Secondary Outcome Measures:
  • Transferrin [ Time Frame: 10 weeks ]
    Transferrin quantitation for laboratory tests (mg/dl)

Other Outcome Measures:
  • Child Growth Indicators [ Time Frame: 10 weeks ]
    Anthropometric measurements as indicators of child growth and nutritional status

Estimated Enrollment: 100
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)
Arms Assigned Interventions
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
Other Names:
  • Chispitas
  • Sprinkles
Placebo Comparator: Placebo
Maltodextrin 1 gram orally on weekdays during 11 weeks
Dietary Supplement: placebo


Ages Eligible for Study:   5 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Assistance to children's centres full day (8 hours).
  • Age 5 to 59 months.

Exclusion Criteria:

  • Anemia (hemoglobin less than 11 g / dl).
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01917032

Contact: Cristian Vargas, MD 573006099044
Contact: Juliana Orozco, Nutritionist 573205371487

Fundación de Atención a la Niñez (FAN) Recruiting
Medellín, Ant, Colombia, 0574
Contact: Viviana Ramírez, Nutricionist    5744480288   
Sponsors and Collaborators
CES University
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
  More Information

Responsible Party: Cristian Vargas G. MD, Student, CES University Identifier: NCT01917032     History of Changes
Other Study ID Numbers: SPRINK001
Study First Received: August 2, 2013
Last Updated: August 5, 2013

Keywords provided by Cristian Vargas G. MD, CES University:
Trace Elements
Fortified Food

Additional relevant MeSH terms:
Nutrition Disorders
Folic Acid
Vitamin A
Trace Elements
Growth Substances
Physiological Effects of Drugs
Vitamin B Complex
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents processed this record on May 25, 2017