NCT02459223

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
Last Updated

June 2, 2015

Status Verified

May 1, 2015

Enrollment Period

3.8 years

First QC Date

May 19, 2015

Last Update Submit

May 31, 2015

Conditions

Undernutrition

Keywords

Nutritional interventioniron deficiency anemia

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Correlations among Anthropometric,Blood and Genetic parameters as a measure of strong or weak relationship.

    3 months

  • ANOVA test and Regression as a measures of statistical marker.

    3 months

Study Arms (2)

Test Group

ACTIVE COMPARATOR

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

Control Group

ACTIVE COMPARATOR

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

Dietary Supplement: Khichadi

Interventions

Nutritional biscuits and khichadiDIETARY_SUPPLEMENT

Nutritional biscuits and Khichadi.

Also known as: Khichadi means Rice cooked with lentiles and spices.
Test Group
KhichadiDIETARY_SUPPLEMENT

Khichadi.

Also known as: Khichadi means Rice cooked with lentiles and spices.
Control Group

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Children above 5 years of either sex.
  • SAM children with various infections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sangeeta Pingale

Nashik, Maharashtra, 422004, India

Location

MeSH Terms

Conditions

MalnutritionAnemia, Iron-Deficiency

Interventions

Spices

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

CondimentsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Sangeeta Pingale, Ph.D.appear

    Maharashtra University of Health Sciences,nashik,Maharashtra,India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI 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 Record Dates

First Submitted

May 19, 2015

First Posted

June 2, 2015

Study Start

February 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 2, 2015

Record last verified: 2015-05

Locations

IN(1)