Growth and Development
Conditions
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.
Interventions
DIETARY_SUPPLEMENTTest Product
MMN fortified beverage powder.
DIETARY_SUPPLEMENTControl
Isocaloric beverage powder without micronutrient fortification.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 10 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Absolute vibriocidal antibody titer | 18 weeks | Blood will be drawn by qualified study personnel as per visits and antibody levels will be assessed. |
| 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. |
Outcome results
None listed