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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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

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Undernutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Nutritional biscuits and khichadi

Intervention Type DIETARY_SUPPLEMENT

Nutritional biscuits and Khichadi.

Control Group

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

Group Type ACTIVE_COMPARATOR

Khichadi

Intervention Type DIETARY_SUPPLEMENT

Khichadi.

Interventions

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Nutritional biscuits and khichadi

Nutritional biscuits and Khichadi.

Intervention Type DIETARY_SUPPLEMENT

Khichadi

Khichadi.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Khichadi means Rice cooked with lentiles and spices. Khichadi means Rice cooked with lentiles and spices.

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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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.

Responsibility Role PRINCIPAL_INVESTIGATOR