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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by CES University
Sponsor:
Information provided by (Responsible Party):
Cristian Vargas G. MD, CES University
ClinicalTrials.gov Identifier:
NCT01917032
First received: August 2, 2013
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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
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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 CES University:

Primary Outcome Measures:
  • Hemoglobin [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Hemoglobin quantitation for laboratory tests (g/dl)


Secondary Outcome Measures:
  • Transferrin [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Transferrin quantitation for laboratory tests (mg/dl)


Other Outcome Measures:
  • Child Growth Indicators [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   5 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01917032

Contacts
Contact: Cristian Vargas, MD 573006099044 crivargas24@hotmail.com
Contact: Juliana Orozco, Nutritionist 573205371487 julianaorozcocano@hotmail.com

Locations
Colombia
Fundación de Atención a la Niñez (FAN) Recruiting
Medellín, Ant, Colombia, 0574
Contact: Viviana Ramírez, Nutricionist    5744480288    nutricion@fan.org.co   
Sponsors and Collaborators
CES University
Investigators
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

No publications provided

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

Keywords provided by CES University:
Trace Elements
Preschool
Malnutrition
Fortified Food

Additional relevant MeSH terms:
Vitamin A
Malnutrition
Nutrition Disorders
Folic Acid
Vitamin B Complex
Micronutrients
Vitamins
Trace Elements
Tretinoin
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 19, 2014