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

Malnutrition Clinical Trial

Official title:

Effect of Home-fortification With Micronutrient Powder Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín: a Randomized Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01917032
• Other study ID #: SPRINK001
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 2, 2013
• Last updated: August 5, 2013
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: August 2013
• Source: CES University
• Contact: Cristian Vargas, MD
• Phone: 573006099044
• Email: crivargas24[@]hotmail.com
• Is FDA regulated: No
• Health authority: Colombia: National Institute of Health
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Months to 59 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malnutrition

Intervention

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

Locations

Country	Name	City	State
Colombia	Fundación de Atención a la Niñez (FAN)	Medellín	Ant

Sponsors (1)

Lead Sponsor	Collaborator
CES University

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child Growth Indicators	Anthropometric measurements as indicators of child growth and nutritional status	10 weeks	No
Primary	Hemoglobin	Hemoglobin quantitation for laboratory tests (g/dl)	10 weeks	No
Secondary	Transferrin	Transferrin quantitation for laboratory tests (mg/dl)	10 weeks	No