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

Primary Purpose

Malnutrition

Status

Unknown status

Phase

Phase 3

Locations

Colombia

Study Type

Interventional

Intervention

Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food

placebo

About this trial

This is an interventional prevention trial for Malnutrition focused on measuring Trace Elements, Preschool, Malnutrition, Fortified Food

Eligibility Criteria

5 Months - 59 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Fundación de Atención a la Niñez (FAN)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sprinkles

Placebo

Arm Description

Micronutrient Powder Sprinkles 1 gram orally on weekdays during 11 weeks

Maltodextrin 1 gram orally on weekdays during 11 weeks

Outcomes

Primary Outcome Measures

Hemoglobin

Hemoglobin quantitation for laboratory tests (g/dl)

Secondary Outcome Measures

Transferrin

Transferrin quantitation for laboratory tests (mg/dl)

Full Information

NCT ID

NCT01917032

First Posted

August 2, 2013

Last Updated

August 5, 2013

Sponsor

CES University

1. Study Identification

Unique Protocol Identification Number

NCT01917032

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2013 (undefined)

Primary Completion Date

November 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

CES University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malnutrition

Keywords

Trace Elements, Preschool, Malnutrition, Fortified Food

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sprinkles

Arm Type

Active Comparator

Arm Description

Micronutrient Powder Sprinkles 1 gram orally on weekdays during 11 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Maltodextrin 1 gram orally on weekdays during 11 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food

Other Intervention Name(s)

Chispitas, Sprinkles

Intervention Description

1 g orally on weekdays during 11 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

Hemoglobin

Description

Hemoglobin quantitation for laboratory tests (g/dl)

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

Transferrin

Description

Transferrin quantitation for laboratory tests (mg/dl)

Time Frame

10 weeks

Other Pre-specified Outcome Measures:

Title

Child Growth Indicators

Description

Anthropometric measurements as indicators of child growth and nutritional status

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Months

Maximum Age & Unit of Time

59 Months

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cristian Vargas, MD

Phone

573006099044

crivargas24@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Juliana Orozco, Nutritionist

Phone

573205371487

julianaorozcocano@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cristian Vargas, MD

Organizational Affiliation

CES University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Juliana Orozco, Nutricionist

Organizational Affiliation

CES University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Juliana Sánchez, Dentist

Organizational Affiliation

CES University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Liliana Montoya, Epidemiology

Organizational Affiliation

CES University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Javier Chica, Veterinarian

Organizational Affiliation

CES University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Maylen Rojas, Epidemiology

Organizational Affiliation

CES University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Óscar Villada, MD

Organizational Affiliation

CES University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Alejandro Díaz, Pediatrist

Organizational Affiliation

CES University

Official's Role

Study Chair

Facility Information:

Facility Name

Fundación de Atención a la Niñez (FAN)

City

Medellín

State/Province

Ant

ZIP/Postal Code

0574

Country

Colombia

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Viviana Ramírez, Nutricionist

Phone

5744480288

nutricion@fan.org.co

12. IPD Sharing Statement

Learn more about this trial

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

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