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

Primary Purpose

Undernutrition

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Nutritional biscuits and khichadi
Khichadi
Sponsored by
Maharashtra University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Undernutrition focused on measuring Nutritional intervention, iron deficiency anemia

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sangeeta Pingale

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Test Group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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
ANOVA test and Regression as a measures of statistical marker.
Two markers were proposed.

Full Information

First Posted
May 19, 2015
Last Updated
May 31, 2015
Sponsor
Maharashtra University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02459223
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maharashtra University of Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition
Keywords
Nutritional intervention, iron deficiency anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Treated with only local food Khichadi (Rice and hulled split green gram cooked together with spices) for the three months period.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional biscuits and khichadi
Other Intervention Name(s)
Khichadi means Rice cooked with lentiles and spices.
Intervention Description
Nutritional biscuits and Khichadi.
Intervention Type
Dietary Supplement
Intervention Name(s)
Khichadi
Other Intervention Name(s)
Khichadi means Rice cooked with lentiles and spices.
Intervention Description
Khichadi.
Primary Outcome Measure Information:
Title
Measurement of Anthropometric Parameters as a measure of improvement in malnutrition.
Description
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.
Time Frame
3 months
Title
Measurement of biochemical Parameters as a measure of improvement in malnutrition.
Description
The level of all blood parameters were noted to be improved from abnormal to normal level in the all enrolled test group malnourished children.
Time Frame
3 months.
Title
Measurement of expression of gene HRI (Heme Regulatory Inhibitor) as a measure of improvement in iron storage and malnutrion.
Description
The expression of Gene HRI was noted to be down regulated in the all enrolled test group malnourished children.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Correlations among Anthropometric,Blood and Genetic parameters as a measure of strong or weak relationship.
Description
There were improvements noted in the Anthropometric and Blood parameters,Gene HRI was also noted to be down-regulated
Time Frame
3 months
Title
ANOVA test and Regression as a measures of statistical marker.
Description
Two markers were proposed.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangeeta Pingale, Ph.D.appear
Organizational Affiliation
Maharashtra University of Health Sciences,nashik,Maharashtra,India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sangeeta Pingale
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422004
Country
India

12. IPD Sharing Statement

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

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