NCT01491581

Brief Summary

The objective of the study is to evaluate the impact of the milk-based nutrient-rich bar, specifically the effect of its fortification with zinc, iodine, vitamins A and D and calcium on nutritional status of school children, focusing on vitamin A and, zinc, iodine, calcium and iron status, and on their cognitive performances.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
415

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2011

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

November 21, 2012

Status Verified

November 1, 2012

Enrollment Period

5 months

First QC Date

November 28, 2011

Last Update Submit

November 20, 2012

Conditions

Cognitive Performance

Keywords

anthropometryzinciodinevitamin Dcalciumschool childrenfood supplement

Outcome Measures

Primary Outcomes (1)

  • micronutrient status

    change in micronutrient status (hemoglobin and serum concentrations of vitamin D, calium, zinc) from baseline to end of the intervention when children have received the food bar for 6 months, 5 days/week.

    6 months intervention study with baseline and endpoint data collection

Secondary Outcomes (1)

  • cognitive function

    6 months intervention study with baseline and endpoint data collection

Study Arms (2)

micronutrient enriched bar

EXPERIMENTAL

bar enriched with micronutrients

Dietary Supplement: food bar

control arm

PLACEBO COMPARATOR

normal bar

Dietary Supplement: food bar

Interventions

food barDIETARY_SUPPLEMENT

milk based food bar enriched with micronutrients

Also known as: Goody
control armmicronutrient enriched bar

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • pupil in one of the 2 selected schools, in grade 1 - 3
  • weight for height \> -3 z-scores
  • hemoglobin concentration \> 70 g/L

You may not qualify if:

  • weight for height \< -3 z-scores
  • hemoglobin concentration \<= 70 g/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Can Do primary school

Can Do, Can Tho City, Vietnam

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

November 28, 2011

First Posted

December 14, 2011

Study Start

December 1, 2011

Primary Completion

May 1, 2012

Study Completion

October 1, 2012

Last Updated

November 21, 2012

Record last verified: 2012-11

Locations

VN(1)