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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Vaccine response test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Test Product (Dietary Supplement)
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.
干预措施: Control (Dietary Supplement)
结局指标
主要结局
Vaccine response test
时间窗: 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.
次要结局
- Change from baseline in nutrional biochemistry(18 weeks)
- Absolute vibriocidal antibody titer(18 weeks)