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

Not Applicable

Withdrawn

• Conditions: Growth and Development
• Interventions: Dietary Supplement: Control; Dietary Supplement: Test Product

• Registration Number: NCT02551627
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-14
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-16
• Study Start: 2016-06-01
• Primary Completion: 2017-10-01
• Study Completion: 2017-10-01
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	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.
Test Product	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.

Primary Outcome Measures

Name	Time	Method
Vaccine response test	18 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in nutrional biochemistry	18 weeks	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.
Absolute vibriocidal antibody titer	18 weeks	Blood will be drawn by qualified study personnel as per visits and antibody levels will be assessed.