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CTRI Number  CTRI/2018/03/012440 [Registered on: 08/03/2018] Trial Registered Retrospectively
Last Modified On: 23/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Ready to use therapeutic food]  
Study Design  Other 
Public Title of Study   Effect of Indigenous Ready to use Therapeutic Food i.e. Medical nutrition therapy on children suffering from severe wasting in age group of 5-10 years. 
Scientific Title of Study   A study of demographic characteristics and impact of Medical Nutrition Therapy in children with severe wasting in the age group 5-10 years 
Trial Acronym   
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, India

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, India


MAHARASHTRA
400022
India 
Phone  9769765309   
Fax    
Email  nrrcproject@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vishal Sawant 
Designation  Professor Pediatrics 
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital  
Address  Department of Pediatrics, L.T.M.M.College & L.T.M.G Hospital, Sion, Mumbai-22, India

Mumbai
MAHARASHTRA
400022
India 
Phone  7666606917  
Fax    
Email  vsawant1989@ymail.com  
 
Source of Monetary or Material Support  
UNICEF, 35, Mahakali Caves Rd, Hanuman Nagar, Andheri East, Mumbai, Maharashtra 400053 
 
Primary Sponsor  
Name  UNICEF 
Address  35, Mahakali Caves Rd, Hanuman Nagar, Andheri East, Mumbai, Maharashtra 400053 
Type of Sponsor  Other [Non-government organisation] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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, Urban health centre (Chota sion hospital First floor, 60 feet road, Dharavi Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 
9769765309

alkaraja1@rediffmail.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  
Health Type  Condition 
Patients  Severe Thinness,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children between 5-10 yrs referred to OPD &/or admitted with Severe Thinness i.e. BMI < -3 SD as per BMI charts by WHO.
 
 
ExclusionCriteria 
Details  1.Children with chronic illnesses
2.Inability to take orally
3.Children already on any nutritional supplements
4. Failed appetite for 3 consecutive days

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) TO assess the efficacy of MNT.
2) To assess the rate of weight gain.
3) To assess the nutritional outcome at the end of 8 weeks. 
1 week, 2week, 3 week, 4 week, 5 week, 6 week, 7 week, 8 week 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the nutritional outcome at the end of 8 weeks.  1 week, 2 week, 3 week, 4 week, 5 week, 6 week, 7 week, 8 week 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
Final Enrollment numbers achieved (Total)= "113"
Final Enrollment numbers achieved (India)="113" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   13/04/2015 
Date of Study Completion (India) 09/01/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The study was carried out in the paediatric department of a large tertiary referral centre from April 2015 to November 2016. All admitted children were subjected to anthropometry i.e. weight and height. BMI was calculated and scrutinized as per WHO standard growth charts 2007. The screened patients were enrolled into study in accordance with the inclusion criteria in the aforesaid study period after informed consent obtained from the parents/guardian. A total of 113 patients were enrolled into the study. They were divided into cases (n=58) & controls (n=55). After obtaining the consent they were subjected to an appetite test. Medical Nutrition Therapy was prepared in the production unit indigenously.

MNT Recipe

                Ingredients

          % weight

               Peanut paste

         25

        Skimmed milk powder

         24

             Powdered sugar

        28

             Soybean oil

20.8

           Micronutrient mix

       1.6

           Emulsifiers

       0.6

 

 

Pack size of 92 grams giving 515 kcal and 13.6 gm proteins and 1.47 gm weight of micronutrients as per WHO specifications.

 The appetite test look up charts is attached below annexure number 6.

Subjects were enrolled after passing the appetite test and a detailed history,clinical examination is carried out in a predesigned pre tested Performa as attachedin the annexure number 4.

As per WHOUNICEF 2009 protocol, cases were given Medical Nutrition Therapy for a period of 8 weeks alongwith nutritional counselling (annexure 5).The controls were given only nutritional counselling.

Nutritional counselling was structured on the following principles.

a)    Minimum Meal Frequency.

b)    Minimum Dietary Diversity.

c)    Emphasis on family based low cost high protein and energy yielding food appropriate to the community and socioeconomic background.

 

 

Detailed history of the patients was obtained.A complete clinical examination of patients at the time of admission including vitals, general examination, a detailed anthropometry with WHO classification for malnutrition and systemic examination was done. These details were filled in predesigned case record form.

The detailed anthropometry wasdone as follows. The weight was taken using standard electronic weighing scale. The height for children was taken using a stadiometer. Body mass index was calculated using formula: weight in kg/ (height in metre)2.
Malnutrition was classified according to the WHO guidelines taking only BMIparameter between five years to ten years. BMI less than three standard deviations were designated as Severe Thinness. Those falling between two and three standard deviations below median were designated as Thinness.

The cases received Medical Nutrition Therapy as per WHO protocol for RUTF (ready to use therapeutic food).

The subjects were followed up every weekly for a period of 8 weeks (duration of MNT received). A detailed anthropometric examination along with clinical examination & nutritional counselling were given to subjects at each visit during follow up.

All these details were recorded in a case record form designed for the study.

 
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