A Study to Investigate the Impact of a Multiple Micronutrient (MMN) Beverage Powder on Vaccine Response in School Children

NCT ID: NCT02551627

Last Updated: 2017-12-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2017-10-01

Brief Summary

This will be a double blind, two-arm, parallel-group, stratified for gender, randomised, controlled study in participants aged 7-10 years (yrs). The aim of the study is to test the hypothesis that MMN fortified beverage may help improve immunity outcomes as assessed through vaccine response in 7-10 yrs old school participants.

Conditions

Growth and Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Test Product

MMN fortified beverage powder \[27 gram (g)\] made up in 150 milliliter (mL) of water, will be administered orally as a single serve, twice daily for 18 weeks.

Group Type: EXPERIMENTAL

Test Product

Intervention Type: DIETARY_SUPPLEMENT

MMN fortified beverage powder.

Control

Isocaloric beverage powder without micronutrient fortification (27 g), made up in 150 mL of water will be administered orally as a single serve, twice daily for 18 weeks.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: DIETARY_SUPPLEMENT

Isocaloric beverage powder without micronutrient fortification.

Interventions

Test Product

MMN fortified beverage powder.

Intervention Type: DIETARY_SUPPLEMENT

Control

Isocaloric beverage powder without micronutrient fortification.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Understanding and willingness to participate in the study as demonstrated by participants' parents and/or Legally acceptable representatives (LARs) voluntary written informed consent, participants' written assent
• Participants aged between 7-10 yrs, inclusive
• Good general and mental health
• Participants with Z-scores of BMI for age of ≥-3 to ≤+1

Exclusion Criteria

• Children in Care (CiC)
• Known or suspected intolerance or hypersensitivity to the study material or any of their stated ingredients or any known food allergies like peanut allergy, gluten allergy or lactose intolerance
• Participant who has already been administered cholera vaccine in any form prior to this study and any known contra-indication to oral cholera vaccine
• Participant who consumed any antibiotics during the week prior to the first dose of study vaccination until the end of the study
• Severe anemia (Hb < 8 g/dL), recent history (2 months) of serious infections, injuries and/or surgeries
• Participant consuming nutritional supplement and/or health food drinks on regular basis (≥ 3 times a week) in last 3 months
• Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder
• Participants likely to move out of geographical range of the study within study duration
• Child of an employee of the sponsor or the study site or members of their immediate family, sibling of participant already enrolled in the study
• Previous participation in this study, in another clinical study or receipt of an investigational drug within 30 days of screening visit; participation in any nutritional study or didactic nutritional education in last 6 months of the screening visit

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

204476

Identifier Type: -

Identifier Source: org_study_id