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

Maharashtra University of Health Sciences

Status: Completed

Conditions: Undernutrition

Treatments: Dietary Supplement: Nutritional biscuits and khichadi; Dietary Supplement: Khichadi

Study type: Interventional

Funder types: Other

Identifiers

NCT02459223

NBT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Children above 5 years of either sex.
• SAM children with various infections.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Test Group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Nutritional biscuits and khichadi

Control Group

Active Comparator group

Description:

Treated with only local food Khichadi (Rice and hulled split green gram cooked together with spices) for the three months period.

Treatment:

Dietary Supplement: Khichadi