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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02459223
Enrollment
105
Registered
2015-06-02
Start date
2009-02-28
Completion date
2012-12-31
Last updated
2015-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Undernutrition

Keywords

Nutritional intervention, iron deficiency anemia

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.

Interventions

DIETARY_SUPPLEMENTNutritional biscuits and khichadi

Nutritional biscuits and Khichadi.

DIETARY_SUPPLEMENTKhichadi

Khichadi.

Sponsors

Maharashtra University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Measurement of Anthropometric Parameters as a measure of improvement in malnutrition.3 monthsAll 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.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.
Measurement of expression of gene HRI (Heme Regulatory Inhibitor) as a measure of improvement in iron storage and malnutrion.3 monthsThe expression of Gene HRI was noted to be down regulated in the all enrolled test group malnourished children.

Secondary

MeasureTime frameDescription
Correlations among Anthropometric,Blood and Genetic parameters as a measure of strong or weak relationship.3 monthsThere 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.3 monthsTwo markers were proposed.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026