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CTRI Number  CTRI/2018/02/012171 [Registered on: 26/02/2018] Trial Registered Retrospectively
Last Modified On: 24/03/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Ready to use therapeutic food]  
Study Design  Other 
Public Title of Study   Efficacy of Indigenously made soya based Ready to use Therapeutic food versus Indigenously made peanut based Ready to use Therapeutic food 
Scientific Title of Study   A Hospital based prospective open randomized controlled trial to compare the efficacy of Soya based Medical Nutrition Therapy (S-MNT) with Peanut based Medical nutritional Therapy (P-MNT) in children with severe acute malnutrition 
Trial Acronym  S-MNT, P-MNT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alka Jadhav 
Designation  Professor Pediatrics 
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital 
Address  Nutritional Rehablitation, Research and Training Centre, Department of Pediatrics, L.T.M.M.College & L.T.M.G Hospital, Sion, Mumbai-22, Mumbai
Dr. Alka Jahdav, Room 120, 1st floor, College building, Dept of Pediatrics, LTMGH and LTMMC, Dr. Babasaheb Ambedkar Road, Sion (West), Mumbai-400022
Mumbai
MAHARASHTRA
400022
India 
Phone  9769765309  
Fax    
Email  nrrcproject@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Alka Jadhav 
Designation  Professor Pediatrics 
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital 
Address  Nutritional Rehablitation, Research and Training Centre, Department of Pediatrics, L.T.M.M.College & L.T.M.G Hospital, Sion, Mumbai-22, Mumbai
Dr. Alka Jadhav, room no. 120, 1st floor, college building, Dept. of Pediatrics, LTMGH and LTMMC, Dr. Babasaheb Ambedkar Road, Sion West, Mumbai-400022
Mumbai
MAHARASHTRA
400022
India 
Phone  9769765309  
Fax    
Email  nrrcproject@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Alka Jadhav 
Designation  Professor Pediatrics 
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital 
Address  Nutritional Rehablitation, Research and Training Centre, Department of Pediatrics, L.T.M.M.College & L.T.M.G Hospital, Sion, Mumbai-22, Mumbai
Dr. Alka Jadhav, room no. 120, 1st floor, college building, Dept. of Pediatrics, LTMGH and LTMMC, Dr. Babasaheb Ambedkar Road, Sion West, Mumbai-400022
Mumbai
MAHARASHTRA
400022
India 
Phone  9769765309  
Fax    
Email  nrrcproject@gmail.com  
 
Source of Monetary or Material Support  
TATA motors Private Limited 
Toddler Food Partners 
 
Primary Sponsor  
Name  Toddler Food Partners 
Address  Minneapolic, USA 
Type of Sponsor  Other [NGO] 
 
Details of Secondary Sponsor  
Name  Address 
Tata Motors Private Limited  CSR department, 2nd floor, teen hath naka,near gyansadhana college, thane(west), maharashtra, india 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Alka Jadhav  Nutritional Rehabilitation, Research and Training Centre  NRRTC, Room no. 110, Dept. of Pediatrics, Urban health centre (Chota sion hospital First floor, 60 feet road, Dharavi
Mumbai
MAHARASHTRA 
9769765309

nrrcproject@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lokmanya tilak municipal medical college and general hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E43||Unspecified severe protein-caloriemalnutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Peanut based Medical Nutrition Therapy  Peanut based Medical Nutrition Therapy consists of peanut paste, skimmed milk powder, soybean oil, powdered sugar, micronutrient premix and emulsifier. 
Comparator Agent  Peanut based Medical Nutrition Therapy  Peanut based Medical Nutrition Therapy consists of peanut paste, skimmed milk powder, soybean oil, powdered sugar, micronutrient premix and emulsifier. 
Intervention  Soya based Medical Nutrition Therapy  Soya based Medical Nutrition Therapy consist of defatted soya flour, skimmed milk powder, soybean oil, powdered sugar, micronutrients premix and emulsifier 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  60.00 Month(s)
Gender  Both 
Details  Children between 6 months to 60 months referred to OPD &/or admitted with SAM as per one of the 3 criteria
(WHO) W/H < -3 SD or
MUAC < 11.5 cm or
Bilateral Pedal edema
 
 
ExclusionCriteria 
Details  1.Children with chronic illnesses
2.Inability to take orally
3.Children already on any nutritional supplements
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1) To assess the efficacy of Soya based MNT in children with SAM without significant chronic medical disease in community.
2) To assess the rate of weight gain.
3) To assess proportion of children achieving weight gain(target weight)
4) To assess the outcome at the end of 8 weeks.
 
2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 6 month 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficacy of Soya based MNT in children with Peanut based MNT.  2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 6 month 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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   N/A 
Date of First Enrollment (India)   01/03/2017 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  
not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

All children who satisfy the criteria for Severe Acute Malnutrition (SAM) will be enrolled in this project after counseling and consent of their parents. Children with SAM having complication will be admitted at LTMGH, Sion. They will be stabilized with F75 and F100 alongwith emergency care and then enrolled in the project. Uncomplicated SAM children will be enrolled at NRRTC on OPD bases. This include immune-compromised (irrespective of ART) as well as children infected with tuberculosis (TB) after ruling out significant underlying disease. They will be treated atleast for period of 14days (maximum 3months) alongwith the mother or caretaker of the child. All the details would be entered in the predesigned and pretested proforma.

1.      Nutritional History: Detailed nutritional assessments will be done at baseline, 2 weekly thereafter for 6 weeks and then monthly for 6 months from the baseline. At each evaluation the history of the child’s eating habits, food allergies and use of nutritional supplements, history of nausea, vomiting, abdominal pain, abdominal distention, and diarrhea or constipation would be assessed.

2.      2. Anthropometric measurements: Weight, height/ length and Mid upper arm circumference (MUAC) would be done at baseline, 2 weekly thereafter for 6 weeks and then monthly for 6 months from the baseline. Weight would be measured to the nearest 100g on a regularly calibrated electronic scale with the child standing barefoot/sleeping and undressed. Height would be measured to the nearest 1 mm using standard measuring techniques; the mean of two readings would be calculated for each child. For measurement of MUAC, with the forearm held perpendicular to the upper arm, a paper measuring tape would be used to record the circumference at the mid-point between the olecranon process of the ulna and the acromial process of the scapula. The mean of 3 measurements was used for analysis.

3. Z-scores would be calculated using published normal reference data. Wt/Ht, MUAC will be plotted on WHO growth charts for evaluation & monitoring of Nutritional status and progress of recovery at least for a period of 4 - 12 months after 6wks of RUTF.   
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