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

Undernutrition Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459223
• Other study ID #: NBT
• Status: Completed
• Phase: N/A
• First received: May 19, 2015
• Last updated: May 31, 2015
• Start date: February 2009
• Est. completion date: December 2012

Study information

• Verified date: May 2015
• Source: Maharashtra University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Undernutrition

Intervention

Dietary Supplement:
• Nutritional biscuits and khichadi
Nutritional biscuits and Khichadi.
• Khichadi
Khichadi.

Locations

Country	Name	City	State
India	Sangeeta Pingale	Nashik	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Maharashtra University of Health Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Anthropometric Parameters as a measure of improvement in malnutrition.	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.	3 months
Primary	Measurement of biochemical Parameters as a measure of improvement in malnutrition.	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 months.
Primary	Measurement of expression of gene HRI (Heme Regulatory Inhibitor) as a measure of improvement in iron storage and malnutrion.	The expression of Gene HRI was noted to be down regulated in the all enrolled test group malnourished children.	3 months
Secondary	Correlations among Anthropometric,Blood and Genetic parameters as a measure of strong or weak relationship.	There were improvements noted in the Anthropometric and Blood parameters,Gene HRI was also noted to be down-regulated	3 months
Secondary	ANOVA test and Regression as a measures of statistical marker.	Two markers were proposed.	3 months