Impact of Multiple Micronutrients Fortified Oral Nutrition Supplements on Physical Growth, Muscle Parameters, Strength, and Cognitive Development in School Aged Children (6-16 years): Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- To assess the efficacy of two high protein-micronutrient fortified drinks on physical growth of school children and adolescents as assessed by BMI-for-age percentiles
研究概览
简要总结
This is a randomized, controlled four-armed study. A total of 1200 mildly malnourished or
normal children, both male and female, aged 6-16 years will be randomized into four arms
equally to ensure at least n=256 completers in each group (at least n=1024 completers in all).
The test groups will receive the high protein micronutrient fortified ONS drinks (ONS 1 and
ONS 2) for 6 months along with dietary counselling (DC). Control group 1 will be receiving
cow’s milk for 6 months and control group 2 will be receiving only dietary counselling.
Counselling sessions will be conducted on Visit 1, Visit 2 and Visit 3. The study groups will
be:
- TEST ARM 1: To receive the new revised 1 RDA compliant micronutrient fortified
ONS 1 along with dietary counselling for 6 months. The ONS 1 (27 g) in 150 ml cow’s
milk twice a day will be supplemented for 6 months.
- TEST ARM 2: To receive the existing micronutrient fortified ONS 2 along with dietary
counselling for 6 months. The ONS 2 (27 g) in 150 ml cow’s milk twice a day will be
supplemented for 6 months.
-
CONTROL ARM 1: To receive 150 ml cow’s milk twice a day for 6 months
-
CONTROL ARM 2: To receive only dietary counselling for 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Normal and mildly malnourished children with BMI-for-age percentiles [between 3rd to 25th percentile (-1.881) to (-0.674) z-score] by calculating as per WHO 5-19 years Growth Reference will be included 2.Screening for anemia will be done to include all children with hemoglobin ≥8 mg/dl 3.Children ≥ 6 years to ≤ 16 years will be included. (25-30 children per age). Stratification of pubertal (10 -15+ years) and prepubertal (6-9+ years) will be done later. Both boys and girls will be included 4.Children should not be lactose intolerant /have lactose sensitivity and be comfortable to have milk daily. [0 – (-1 SD) are normal children; (−1 to −1.9 SD) is defined as mild malnutrition; [−2 to −2.9 SD) is defined as moderate malnutrition; [(≥ −3) is defined as severe malnutrition]. [mild anaemia defined as 11 – 11.49 and 11 – 11.99 mg/dl for children 5-11 years and 12-14 years respectively; moderate anaemia defined as
- •10.99 mg/dl for children 5-11 years and 12-14 years respectively].
排除标准
- •Children will be excluded at the time of screening, if they had been diagnosed or were known to: 1.be lactose intolerant and galactosaemic 2.be allergic or intolerant to wheat / any other cereal 3.have a current acute or chronic infection including but not restricted to respiratory infection, diarrhoea, Hepatitis B or C, HIV infection or tuberculosis.
- •4.have severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis; have a diagnosis of neoplastic, renal, hepatic or cardiovascular disease, hormonal or metabolic disorders, congenital disease or genetic disorders such as atrial or ventricular wall defects, or Down’s syndrome, infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or developmental delay.
- •5.diagnosed with disorders of haemoglobin structure, function, or synthesis according to medical records or parent/guardian report, or 6.have been diagnose with ADHD, any form of delayed / impaired cognitive development, delayed developmental milestones, or is on any form of medication for other cognitive conditions.
- •7.have had a clinically significant nutritional deficiency requiring specific treatment with another similar nutritional supplement (other than the study product) or 8.have any other clinically significant medical condition, which, in the investigator’s opinion, made the child unsuitable for inclusion in the study.
结局指标
主要结局
To assess the efficacy of two high protein-micronutrient fortified drinks on physical growth of school children and adolescents as assessed by BMI-for-age percentiles
时间窗: 6 Months
次要结局
- To assess the efficacy of two high protein micronutrient fortified drinks on school children (6 – 16 years) as assessed by(Anthropometric parameters)
研究者
Dr Anuradha Khadilkar
Jehangir Clinical Development Centre Pvt Ltd