Open Label Prospective Parallel Group Active Comparator Interventional Study to Determine the Efficacy of the Therapeutic Nutritional Intervention in SAM Category Malnourished Children of Satpuda Region.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Measurement of Anthropometric Parameters as a measure of improvement in malnutrition.
研究概览
简要总结
Present study was designed to evaluate the efficacy of the nutritional intervention, in the SAM (Severe Acute malnutrition)children by monitoring various Anthropometric,Biochemical ,Hormonal and Enzymatic parameters before and after the nutritional intervention treatment.This study was also intended to study possible functional role of gene HRI (heme regulated inhibitor) as a molecular marker for the early detection of iron deficiency anemia in malnourished children similarly present study has also tried to find anthropometric marker and different correlations among study parameters.
详细描述
In India, child malnutrition is responsible for 22% of the country's burden of disease. Development of local therapeutic nutritional intervention is highly recommended by WHO. Present study was designed to evaluate the efficacy of the nutritional intervention, as well as to study HRI (heme regulated inhibitor) gene expression, to suggest it as a molecular marker for the early detection of iron deficiency anemia in malnourished children also to find anthropometric marker and different correlations of study parameters.
105 test and 100 control SAM (Severe Acute malnutrition) children without infection, of 1 to 5 years of age and either sex were enrolled. Test group was given treatment of nutritional intervention therapy (NIT), providing 2.5 to 3gm Protein and 90-100kcal/kg body Weight/day, for the three months period. Their Anthropometric, Enzymatic, Biochemical and Hormonal parameters were measured before and after the NIT. Correlation of serum triglyceride with weight for height% , as well as correlation of HRI with Mean corpuscular hemoglobin,(MCH) was studied. Similarly status of Hairs, Skin, oedema, WHO z- score,and BMR was also studied before and after the NIT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects from age group of 1 to 5 years of either sex belonging to SAM (Severe Acute Malnutrition) category and provided Therapeutic Nutritional Biscuit's treatment.
- •Subjects from age group of 1 to 5 years of either sex belonging to SAM and not taking nutritional Biscuit's treatment, included as a control for comparative study.
排除标准
- •Children above 5 years of either sex.
- •SAM children with various infections.
研究组 & 干预措施
Test Group
Treated with nutritional biscuits and khichadi. Nutritional biscuits providing 2.5 to 3 gm Protein and 90-100kcal/kg body Weight/day, as well as local food Khichadi (Rice and hulled split green gram cooked together with spices) for the three months period.
干预措施: Nutritional biscuits and khichadi (Dietary Supplement)
Control Group
Treated with only local food Khichadi (Rice and hulled split green gram cooked together with spices) for the three months period.
干预措施: Khichadi (Dietary Supplement)
结局指标
主要结局
Measurement of Anthropometric Parameters as a measure of improvement in malnutrition.
时间窗: 3 months
All the enrolled test group malnourished children have put on weight at a rate of 5 g/kg/day and their WHO z-score for weight and Height were improved from -3 to -1 Or Normal, as well as MUAC improved to normal and edema was absent.
Measurement of biochemical Parameters as a measure of improvement in malnutrition.
时间窗: 3 months.
The level of all blood parameters were noted to be improved from abnormal to normal level in the all enrolled test group malnourished children.
Measurement of expression of gene HRI (Heme Regulatory Inhibitor) as a measure of improvement in iron storage and malnutrion.
时间窗: 3 months
The expression of Gene HRI was noted to be down regulated in the all enrolled test group malnourished children.
次要结局
- Correlations among Anthropometric,Blood and Genetic parameters as a measure of strong or weak relationship.(3 months)
- ANOVA test and Regression as a measures of statistical marker.(3 months)
研究者
Sangeeta Pingale
Open label prospective parallel group active comparator interventional study to determine the efficacy of the therapeutic nutritional intervention in SAM category malnourished children of satpuda region.
Maharashtra University of Health Sciences