NCT02551627撤回不适用
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
适应症
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
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)
研究者
相似试验
已完成
不适用
fMRI Study to Investigate Hemodynamic Changes in Brain Resulting From Supplementation of Bacopa Monnieri Extract and Multiple Micronutrient Supplementation.Growth and DevelopmentNCT02345187GlaxoSmithKline80
已完成
3 期
Dietary Supplement on Symptom Awareness and Heart Rhythm in Patients With Cardiac ArrhythmiaCardiac ArrhythmiaNCT02652338Trommsdorff GmbH & Co. KG74
Unknown
不适用
Effects of Inulin and Arabinoxylan on Satiety, Energy/Food Intake and Changes in the Human Gut MicrobiotaOverweight and ObesityNCT02846454University of Reading33
已完成
不适用
The effect of oral high-micronutrient nutritional supplements on lipid profile in underweight hypertensive pregnant womeISRCTN15485068Khyber Medical University48
已完成
不适用
Micronutrient supplementation for improving micronutrient status in underweight and overweight/obese primary school childreAnaemiaMicronutrient status of primary school childrenUnderweightOverweight and obesityBlood - AnaemiaDiet and Nutrition - Other diet and nutrition disordersDiet and Nutrition - ObesityACTRN12616001245482Dr Ewa Szymlek-Gay348