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

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.

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.

Study Overview

• Status: Completed
• Conditions: Undernutrition
• Intervention / Treatment: Dietary supplement: Nutritional biscuits and khichadi; Dietary supplement: Khichadi

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Nashik, Maharashtra, India, 422004
      • Sangeeta Pingale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Dietary supplement: Nutritional biscuits and khichadi; Nutritional biscuits and Khichadi.; Other Names: Khichadi means Rice cooked with lentiles and spices.
Active Comparator: Control Group; Treated with only local food Khichadi (Rice and hulled split green gram cooked together with spices) for the three months period.	Dietary supplement: Khichadi; Khichadi.; Other Names: Khichadi means Rice cooked with lentiles and spices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
ANOVA test and Regression as a measures of statistical marker.	Two markers were proposed.	3 months

Collaborators and Investigators

• Sponsor: Maharashtra University of Health Sciences
• Investigators: Principal Investigator: Sangeeta Pingale, Ph.D.appear, Maharashtra University of Health Sciences,nashik,Maharashtra,India

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: May 31, 2015
• First Posted (Estimate): June 2, 2015

Study Record Updates

• Last Update Posted (Estimate): June 2, 2015
• Last Update Submitted That Met QC Criteria: May 31, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: iron deficiency anemia; Nutritional intervention
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: NBT