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

NCT02551627 | Withdrawn

• 1 other identifier: 204476
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Absolute vibriocidal antibody titer

  18 weeks

• Change from baseline in nutrional biochemistry

  18 weeks

Study Arms (2)

Test Product

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Test Product DIETARY_SUPPLEMENT

MMN fortified beverage powder.

Test Product

Control DIETARY_SUPPLEMENT

Isocaloric beverage powder without micronutrient fortification.

Control

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 16, 2015
• Study Start: June 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 20, 2017

Record last verified: 2017-12