NCT02542865已完成不适用
Clinical Study to Measure the Impact of Fortified Malt Based Food on Immunity Outcomes in School Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 924
- 试验地点
- 2
- 主要终点
- Total Number of Ill Days Due to Gastrointestinal (GI) and Respiratory Illness at Month 9
研究概览
简要总结
This study will test the hypothesis that a fortified malt based food may improve immunity outcomes in 7-10 year old school age children.
详细描述
This will be a single centre, multiple sites, open label, two-arm, parallel-group, stratified by gender, matched pair cluster randomised, controlled study in children aged 7-10 years.
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
- None
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
- •Demonstrates understanding of the study and willingness to participate as evidenced by the parent's and/or LAR's voluntary written informed consent as well as written assent by the child and has received a signed and dated copyof the informed consent form as well as the assent form.
- •Boys and girls aged between 7-10 years
- •Child and parent/LAR understand and are willing, able and likely to comply with all study procedures and restrictions.
- •Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon physical examination and absence of any condition that could affect the child's safety or wellbeing or their ability to understand and follow study procedures and requirements.
- •Participants with HAZ of ≥-3 to ≤-1.
排除标准
- •Children in Care (CiC): A child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed legal guardian.
- •Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •Indication that child is likely to move out of geographical range of the study within the period of study intervention and activities, thus hindering the child's compliance to study activities.
- •Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit, participation in any nutritional study or didactic nutrition education in the last 6 months of the screening visit and previous participation in this study.
- •Child with severe anaemia (Hemoglobin <8g/dL).
- •Children with history of use of immunosuppressive therapy e.g. oral corticosteroids or chemotherapy in past six months prior to the screening visit.
- •Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant unlikely to fully complete the study or any condition that presents undue risk from the test product or procedures, on the discretion of study physician.
- •Recent history [2 months] of serious infections, injuries and/ or surgeries in the opinion of the investigator.
- •Children consuming nutritional supplements and/or health food drinks on a regular basis (≥3 times a week) in last 3 months.
- •Child belonging to an employee of the sponsor or the study site or members of their immediate family or sibling of a child already enrolled in the study.
结局指标
主要结局
Total Number of Ill Days Due to Gastrointestinal (GI) and Respiratory Illness at Month 9
时间窗: At month 9
Number of days a participant was ill due to GI and/or respiratory illness as diagnosed by physician, as per criteria defined, over the intervention duration. This equals total number of days (symptomatic or asymptomatic) in illnesses episodes whereas each episode is defined as an incidence of illness followed by at least 3 symptoms free days. GI illness was defined as an acute illness that includes any of following symptoms:3 or more loose/liquid/watery stools and/or vomiting in 24hours (h). Respiratory illness was defined as an acute illness that included more than or equal to \[\>=\] 1 of the following symptoms: runny nose, stuffy or blocked nose, cough fever or chills, sore throat or sneezing.
次要结局
- Frequency of GI and Respiratory Illnesses at Month 9(At month 9)
- Severity of GI Illnesses at Month 9(At month 9)
- Severity of Respiratory Illnesses at Month 9(At month 9)
- School Absenteeism Assessment Due to GI and Respiratory Illnesses at Month 9(At month 9)
- Change From Baseline in Body Mass Index (BMI) at Month 9(At screening and month 9)
- Change From Baseline in Gut Integrity/ Health Measured by Urine Lactulose: Mannitol Test at Month 9(At baseline and month 9)
- Change From Baseline in Gut Integrity/ Health Using Urinary Neopterin Assessment at Month 9(At baseline and month 9)
- Change From Baseline in Mucosal Immunity Using Salivary Immunoglobulin A (IgA) Assessment at Month 9(At baseline and month 9)
- Change From Baseline in Serum Levels of Micronutrient Vitamin A and Trace Elements Zinc (Zn), Copper (Cu) and Iron (Fe) at Month 9(At baseline and month 9)
- Change From Baseline in Serum Levels of Trace Element Selenium (Se) at Month 9(At baseline and month 9)
- Change From Baseline in Serum Levels of Micronutrient Vitamin B12 at Month 9(At baseline and month 9)
- Change From Baseline in Serum Levels of Micronutrients Vitamin-D and Serum Folate at Month 9(At baseline and month 9)
- Change From Baseline in Serum Levels of Micronutrient Vitamin-E at Month 9(At baseline and month 9)
- Change From Baseline in Serum Levels of Ferritin Using Blood Testing at Month 9(At baseline and month 9)
- Change From Baseline in Levels of Serum Transferrin Receptor (sTfR) Using Blood Testing at Month 9(At baseline and month 9)
- Change From Baseline in Serum Levels of C-reactive Protein (CRP) and Alpha 1-acid Glycoprotein (AGP) Using Blood Testing at Month 9(At baseline and month 9)
- Change From Baseline in Individual Dietary Diversity Score (IDDS) at Month 9(At baseline and month 9)
- Change From Baseline in Protein, Carbohydrates and Fat Consumption at Month 9(At baseline and month 9)
- Change From Baseline in Energy Consumption at Month 9(At baseline and month 9)
研究者
研究点 (2)
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