UndernutritionNCT02459223
Study of Blood Parameters of the Malnourished Children: Before and After Giving Nutritional Biscuit's Treatment
A study testing Nutritional biscuits and khichadi and Khichadi in people with Undernutrition, run by Maharashtra University of Health Sciences at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Undernutrition
- What is being tested?
- Nutritional biscuits and khichadi and Khichadi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Children above 5 years of either sex.
- SAM children with various infections.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Undernutrition
- Being tested
- Nutritional biscuits and khichadi, Khichadi
- Keywords
- Nutritional intervention, iron deficiency anemia
- Medical subject headings
- Malnutrition, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional biscuits and khichadiDietary supplement
Also called Khichadi means Rice cooked with lentiles and spices.
Nutritional biscuits and Khichadi.
KhichadiDietary supplement
Also called Khichadi means Rice cooked with lentiles and spices.
Khichadi.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Khichadi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (2)
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
Measured: 3 months
ANOVA test and Regression as a measures of statistical marker.
Two markers were proposed.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startFeb 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharashtra University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangeeta Pingale, Maharashtra University of Health Sciences
- Investigators
- Sangeeta Pingale, Ph.D.appear, Principal investigator, Maharashtra University of Health Sciences,nashik,Maharashtra,India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459223
- Sponsor's protocol ID
- NBT
- Status last verified
- May 2015
- First submitted
- 19 May 2015
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02459223
- Acronym / sponsor ID
- NBT
- Conditions
- Undernutrition
- Keywords
- Nutritional intervention, iron deficiency anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Maharashtra University of Health SciencesUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Active comparator | Dietary Supplement: Nutritional biscuits and khichadiTreated 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. |
| Control Group | Active comparator | Dietary Supplement: KhichadiTreated with only local food Khichadi (Rice and hulled split green gram cooked together with spices) for the three months period. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Children above 5 years of either sex.
- SAM children with various infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional biscuits and khichadiAlso: Khichadi means Rice cooked with lentiles and spices.Nutritional biscuits and Khichadi. | Dietary supplement | Test Group |
| KhichadiAlso: Khichadi means Rice cooked with lentiles and spices.Khichadi. | Dietary supplement | Control Group |
Primary outcome
Measurement of Anthropometric Parameters as a measure of improvement in malnutrition.
Time frame: 3 months
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.
Time frame: 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.
Time frame: 3 months
The expression of Gene HRI was noted to be down regulated in the all enrolled test group malnourished children.
2 secondary outcomes
Correlations among Anthropometric,Blood and Genetic parameters as a measure of strong or weak relationship.
Time frame: 3 months
ANOVA test and Regression as a measures of statistical marker.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangeeta Pingale, Ph.D.appear principal investigator
Maharashtra University of Health Sciences,nashik,Maharashtra,India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional biscuits and khichadi and Khichadi in people with Undernutrition, run by Maharashtra University of Health Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Anthropometric Parameters as a measure of improvement in malnutrition. (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.