Clinical Trials Directory

Trials / Completed

CompletedNCT02459223

Study of Blood Parameters of the Malnourished Children: Before and After Giving Nutritional Biscuit's Treatment

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
105 (actual)
Sponsor
Maharashtra University of Health Sciences · Academic / Other
Sex
All
Age
1 Year – 5 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTNutritional biscuits and khichadiNutritional biscuits and Khichadi.
DIETARY_SUPPLEMENTKhichadiKhichadi.

Timeline

Start date
2009-02-01
Primary completion
2012-12-01
Completion
2012-12-01
First posted
2015-06-02
Last updated
2015-06-02

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT02459223. Inclusion in this directory is not an endorsement.