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

Impact of a Multiple Micronutrient (MMN) Beverage Powder on Vaccine Response in School Children (7-10yrs; Inclusive) in Bangladesh: a Randomised, Double Blind Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Growth and Development
• Intervention / Treatment: Dietary supplement: Test Product; Dietary supplement: Control

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Test Product; MMN fortified beverage powder.
Active Comparator: 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.	Dietary supplement: Control; Isocaloric beverage powder without micronutrient fortification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine response test	Proportion of participants demonstrating vaccine reponse, receiving either test product or control will be determined and compared. Vaccine response will be defined as greater than or equal to 4 fold increase from pre-vaccine visit in vibriocidal antibody response 7 days post second vaccine dose.	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute vibriocidal antibody titer	Blood will be drawn by qualified study personnel as per visits and antibody levels will be assessed.	18 weeks
Change from baseline in nutrional biochemistry	Change in nutritional biochemistry for micronutrients vitamins A, B6, B12, C, D, E, folate and of the trace elements (selenium, zinc, copper, iron), ferritin, serum transferrin receptor (sTfR), C-reactive protein (CRP), alpha 1-acid glycoprotein (AGP) from baseline to end of the intervention will be measured from the drawn blood.	18 weeks

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: September 14, 2015
• First Submitted That Met QC Criteria: September 14, 2015
• First Posted (Estimate): September 16, 2015

Study Record Updates

• Last Update Posted (Actual): December 20, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 204476