Study of Blood Parameters of the Malnourished Children: Before and After Giving Nutritional Biscuit's Treatment
- Conditions
- Undernutrition
- Interventions
- Dietary Supplement: Nutritional biscuits and khichadiDietary Supplement: Khichadi
- Registration Number
- NCT02459223
- Lead Sponsor
- Maharashtra University of Health Sciences
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- 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.
- Children above 5 years of either sex.
- SAM children with various infections.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test Group Nutritional biscuits and khichadi 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. Control Group Khichadi Treated with only local food Khichadi (Rice and hulled split green gram cooked together with spices) for the three months period.
- Primary Outcome Measures
Name Time Method Measurement of Anthropometric Parameters as a measure of improvement in malnutrition. 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. 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. 3 months The expression of Gene HRI was noted to be down regulated in the all enrolled test group malnourished children.
- Secondary Outcome Measures
Name Time Method Correlations among Anthropometric,Blood and Genetic parameters as a measure of strong or weak relationship. 3 months There were improvements noted in the Anthropometric and Blood parameters,Gene HRI was also noted to be down-regulated
ANOVA test and Regression as a measures of statistical marker. 3 months Two markers were proposed.
Trial Locations
- Locations (1)
Sangeeta Pingale
🇮🇳Nashik, Maharashtra, India