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

August 5, 2013 updated by: Cristian Vargas G. MD, CES University

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Ant
      • Medellín, Ant, Colombia, 0574
        • Fundación de Atención a la Niñez (FAN)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 4 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Sprinkles
  • Chispitas
PLACEBO_COMPARATOR: Placebo
Maltodextrin 1 gram orally on weekdays during 11 weeks
Dietary supplement: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin
Time Frame: 10 weeks
Hemoglobin quantitation for laboratory tests (g/dl)
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transferrin
Time Frame: 10 weeks
Transferrin quantitation for laboratory tests (mg/dl)
10 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Growth Indicators
Time Frame: 10 weeks
Anthropometric measurements as indicators of child growth and nutritional status
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ANTICIPATED)

November 1, 2013

Study Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

August 2, 2013

First Submitted That Met QC Criteria

August 5, 2013

First Posted (ESTIMATE)

August 6, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 6, 2013

Last Update Submitted That Met QC Criteria

August 5, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPRINK001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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