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

Growth and Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02551627
• Other study ID #: 204476
• Status: Withdrawn
• Phase: N/A
• First received: September 14, 2015
• Last updated: December 19, 2017
• Start date: June 1, 2016
• Est. completion date: October 1, 2017

Study information

• Verified date: December 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Growth and Development

Intervention

Dietary Supplement:
• Test Product
MMN fortified beverage powder.
• Control
Isocaloric beverage powder without micronutrient fortification.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Absolute vibriocidal antibody titer	Blood will be drawn by qualified study personnel as per visits and antibody levels will be assessed.	18 weeks
Secondary	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