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NCT Number: NCT02459223

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

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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Key information

Conditions

Undernutrition Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sangeeta Pingale

Nashik, Maharashtra, 422004, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional biscuits and khichadi

Dietary Supplement

Nutritional biscuits and Khichadi.

Other names: Khichadi means Rice cooked with lentiles and spices.

Khichadi

Dietary Supplement

Khichadi.

Other names: Khichadi means Rice cooked with lentiles and spices.

Primary outcomes

  1. Measurement of Anthropometric Parameters as a measure of improvement in malnutrition.

    Time frame: 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.

  2. Measurement of biochemical Parameters as a measure of improvement in malnutrition.

    Time frame: 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.

  3. Measurement of expression of gene HRI (Heme Regulatory Inhibitor) as a measure of improvement in iron storage and malnutrion.

    Time frame: 3 months

    The expression of Gene HRI was noted to be down regulated in the all enrolled test group malnourished children.

Secondary outcomes

  1. Correlations among Anthropometric,Blood and Genetic parameters as a measure of strong or weak relationship.

    Time frame: 3 months

    There were improvements noted in the Anthropometric and Blood parameters,Gene HRI was also noted to be down-regulated

  2. ANOVA test and Regression as a measures of statistical marker.

    Time frame: 3 months

    Two markers were proposed.

Sponsors and collaborators

Lead sponsor

Maharashtra University of Health Sciences

Other

Registry information

Official study title

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.

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 2, 2015
Registry last updated
Jun 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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