| CTRI Number |
CTRI/2024/01/061109 [Registered on: 04/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A community based study on locally prepared food for treating severe malnourished children of 6-59 months |
|
Scientific Title of Study
|
Use of Energy Dense Food (EDF)/ Locally prepared therapeutic food for community based management in children aged 6- 59 months with Severe Acute Malnutrition |
| Trial Acronym |
SAM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kapil Yadav |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, AIIMS, New Delhi |
| Address |
Room No.37, Centre for Community Medicine, All India Institute of Medical Sciences, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9818420553 |
| Fax |
|
| Email |
dr.kapilyadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil Yadav |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, AIIMS, New Delhi |
| Address |
Room No.37, Centre for Community Medicine, All India Institute of Medical Sciences, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9818420553 |
| Fax |
|
| Email |
dr.kapilyadav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kashish Vohra |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Medical Sciences, AIIMS, New Delhi |
| Address |
Room No.38, Centre for Community Medicine, All India Institute of Medical Sciences, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
7838634350 |
| Fax |
|
| Email |
kashish.1592@gmail.com |
|
|
Source of Monetary or Material Support
|
| Work: PhD Dissertation
Institute/ Hospital: Centre for Community Medicine (CCM), All India Institute of Medical Sciences, AIIMS, New Delhi
Sponsor: NIL |
|
|
Primary Sponsor
|
| Name |
Kashish Vohra |
| Address |
Room No.38, Centre for Community Medicine, All India Institute of Medical Sciences, AIIMS, New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kapil Yadav |
All India Institute of Medical Sciences, AIIMS, New Delhi |
Room No. 37, Centre for Community Medicine, Old OT Block, All India Institute of Medical Sciences, AIIMS, New Delhi-110029, India (Field Work: Nuh Block, Haryana)
South
DELHI |
9818420553
dr.kapilyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee of the All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children aged 6-59 months suffering from Severe Acute Malnutrition without medical complications at the community level |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Balamrutham + |
Duration of intervention will be 16 weeks. Follow-up will be done every fortnightly and endline assessment at the end of 17th week. |
| Comparator Agent |
Ready to Use Therapeutic Food |
Duration of intervention will be 16 weeks. Follow-up will be done every fortnightly and endline assessment at the end of 17th week. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
59.00 Month(s) |
| Gender |
Both |
| Details |
1. Children aged 6 - 59 months with Severe Acute Malnutrition based on following criteria:
a) Weight for length/height z-score (WHZ) <-3SD
b) No Bilateral pitting oedema and no medical complication
2. Children whose families were likely to remain in the study area over the next 4-5 months, and residing in the same at least for the past six months.
3. Children with Severe Acute Malnutrition passing appetite test.
4. Children with above criteria and parent gives informed consent to participate.
|
|
| ExclusionCriteria |
| Details |
1. Children with Severe Acute Malnutrition and having any acute medical complications (they will be referred to facility based care for initial management / stabilization).
2. Bilateral pitting oedema of any grade.
3. Children where parent rejects to participate.
4. Children with severe illness requiring hospitalisation, haemoglobin <5 g/dL, and who are unable to consume the appetite test feed.
5. Children with congenital anomalies, cerebral palsy, neurogenerative disorders.
6. Children’s who do not have living parents.
7. Children with Co-morbid illness or systemic diseases, malabsorption, irritable bowel syndrome or celiac diseases, chronic diarrhea and chronic infections (HIV, Tuberculosis).
8. Children who have undergone any major surgery in last 6 months. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Weight gain: change in g/kg/day between baseline and recovery or 16 weeks of intervention, whichever will be earlier. We will also document the change in weight standard deviation scores from baseline and at different time points of follow up.
2. Recovery/ Discharged/ Cured: WHZ ≥ −2 SD of the WHO standards and absence of oedema of feet at the end of 16-week follow-up
3. Relapse: children hospitalized or develop medical complication at any stage that requires admission (transferred out) and lost to follow-up over 16 weeks of intervention
4. Non responder: Cases who do not meet discharge criteria after 16 weeks |
16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mortality rate
2. Height gain
3. Hemoglobin status
4. Adverse outcomes of other illness: occurrence of diarrhoea/ fever, RTI etc measured at any time during the 16 weeks of intervention
5. Acceptability of RUTF/ B+
6. Adherence to treatment
|
16 week |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Severe Acute Malnutrition (SAM) is defined
by weight-for-height/length Z- score below -3 SD of the median WHO child growth
standards AND/ OR MUAC <11.5cm AND/OR by the presence of bilateral pitting
edema. SAM significantly increases the risk of death in children under-
five years of age. The current prevalence of SAM in India (NFHS 5) is 7.7% with
a rise of 0.2% from NFHS-4 in 2016 (7.5%). Prevalence of SAM in Haryana is
4.4% (NFHS 5). In India, children with SAM and medical complications should be
admitted in health facility. Approximately 85-90% of severely malnourished
children who do not have any medical complications can be taken care of on as
outpatient basis in a community setting, using Energy Dense Food (EDF)-
Augmented THR and other home based food items and routine medicines to treat
simple medical conditions. Currently there is no guidelines by government of India on management of Community
based Management of Acute Malnutrition (CMAM) children. However, many countries
(60+) and States (12) in India developed specific CMAM guidelines. WHO
released guidelines in 2007 that recommends Ready to Use Therapeutic Food
(RUTF) for homebased management of uncomplicated SAM, but acceptance of this
recommendation is limited in India. Locally produced RUTF/ Augmented Take Home
Ration using indigenous foods may be less expensive and more sustainable if its
efficacy could be proved. Reviews, including the most recent Cochrane review
(2013), recommend well-designed, adequately powered, pragmatic randomised
trials to compare treatment options for home-based management of uncomplicated
SAM. Currently the state of Telangana in India has started
the Supervised Supplementary Feeding program to strengthen the CMAM component
and introduced ‘Balamrutham Plus’, a calorie and protein dense fortified food
for treatment of SAM and Moderate Acute Malnutrition (MAM). In
Haryana, Mewat is an aspirational district of government of India where the
prevalence of SAM is 7.1 %. Thus, the study will be conducted to compare the
efficacy of Balamrutham Plus Vs standard RUTF on the nutritional status of children 6
to 59 months age with uncomplicated SAM in Mewat district, Haryana. Also, the study aims to look at the holistic approach for community based
management of acute malnutrition (CMAM) among uncomplicated SAM children
starting from exploring the factors effecting SAM and to critically appraise
the evidence and policy environment around CMAM.
|