NCT01415557

Brief Summary

The purpose of this study is to assess the impact of regular consumption of micronutrient fortified drink in improving nutritional and micronutrient status in Indian school children. The test beverage will be fortified with both, vitamins and minerals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
227

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 12, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 7, 2013

Status Verified

November 1, 2013

Enrollment Period

7 months

First QC Date

July 22, 2011

Last Update Submit

November 5, 2013

Conditions

Healthy

Keywords

micronutrienthealthy childrenvitaminsmineralscognitionphysical performanceironMicronutrient statusCognitive Performance

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the micronutrient status in the study subjects at 6 months

    The primary outcome measures will be change from baseline in the micronutrient status in the study subjects at end of intervention.

    6 months

Secondary Outcomes (6)

  • Change from baseline in cognitive performance at 6 months

    6 months

  • Change from baseline in the physical performance at 6 months

    6 months

  • Change from baseline in the fatigue score at 6 months

    Baseline and Endline (six months)

  • Morbidity Assessment

    6 months

  • Prevalence of Micronutrient Deficiency

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Non-Fortified Control Product

PLACEBO COMPARATOR

Non-fortified control beverage

Other: Non-Fortified Control Product

Micronutrient Fortified Test Product

ACTIVE COMPARATOR

Micronutrient fortified test beverage

Other: Micronutrient Fortified Test Product

Interventions

Non-Fortified Control ProductOTHER

Non-Fortified Control Beverage

Non-Fortified Control Product
Micronutrient Fortified Test ProductOTHER

Micronutrient Fortified Test Beverage

Micronutrient Fortified Test Product

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Apparently healthy school going children
  • not severely malnourished weight-for-height z-score ≥-2 not severely anemic (Hb\<8g/dl)
  • Age: 7-10 years
  • Not taking any food supplements/fortified drinks
  • Not planning to move out during the study duration

You may not qualify if:

  • Age: \<7 and \>10 years
  • Severe anemia (Hb \< 8 g/dl)
  • Severely malnourished children with weight-for-height z-score \<-3 will be excluded.
  • Cardiovascular disease on clinical examination or history
  • Underlying respiratory disease with impairment of lung function
  • Physical disability which can interfere or limit performance of tests
  • Recent history (3 months prior) of serious infections, injuries and/ or surgeries
  • Any food allergy or food intolerance
  • Participation in any nutritional study in the last 1year
  • Children consuming nutritional supplements and/ or health food drinks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Johns Research Institute

Bangalore, Karnataka, 560034, India

Location

Related Publications (1)

  • Kuriyan R, Thankachan P, Selvam S, Pauline M, Srinivasan K, Kamath-Jha S, Vinoy S, Misra S, Finnegan Y, Kurpad AV. The effects of regular consumption of a multiple micronutrient fortified milk beverage on the micronutrient status of school children and on their mental and physical performance. Clin Nutr. 2016 Feb;35(1):190-198. doi: 10.1016/j.clnu.2015.02.001. Epub 2015 Feb 21.

    PMID: 25746819DERIVED

Study Officials

  • Prashanth Thankachan, PhD

    St. John's Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2011

First Posted

August 12, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2012

Study Completion

September 1, 2012

Last Updated

November 7, 2013

Record last verified: 2013-11

Locations

IN(1)