Clinical trial NCT02459223: Study of Blood Parameters of the Malnourished Children: Before and After Giving Nutritional Biscuit's Treatment
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undernutrition
Keywords: Nutritional intervention
iron deficiency anemia
Lead sponsor: Maharashtra University of Health Sciences
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 105
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of Anthropometric Parameters as a measure of improvement in malnutrition.
timeFrame: 3 months
measure: Measurement of biochemical Parameters as a measure of improvement in malnutrition.
timeFrame: 3 months.
measure: Measurement of expression of gene HRI (Heme Regulatory Inhibitor) as a measure of improvement in iron storage and malnutrion.
timeFrame: 3 months
Secondary outcomes:
measure: Correlations among Anthropometric,Blood and Genetic parameters as a measure of strong or weak relationship.
timeFrame: 3 months
measure: ANOVA test and Regression as a measures of statistical marker.
timeFrame: 3 months
Other outcomes:
Locations:
city: Nashik
country: India
facility: Sangeeta Pingale
state: Maharashtra
Study officials:
affiliation: Maharashtra University of Health Sciences,nashik,Maharashtra,India
name: Sangeeta Pingale, Ph.D.appear
role: PRINCIPAL_INVESTIGATOR
References: