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CTRI Number  CTRI/2024/11/077369 [Registered on: 26/11/2024] Trial Registered Prospectively
Last Modified On: 27/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the weight gain per day in a SAM child using a new diet inclusive of adequate calorie and protein requirements.  
Scientific Title of Study   To study the effect of a new diet in terms of weight gain per day, designed to supplement the calorie and protein requirements in a SAM child 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr NEHAL ATHREYI R 
Designation  Junior resident 
Affiliation  RNT medical college  
Address  2nd year Resident, Department of Paediatrics RNT medical college Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9880012727  
Fax    
Email  nehalathreyi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohammad Asif 
Designation  Professor and Unit Head 
Affiliation  RNT medical college  
Address  Department of Paediatrics RNT Medical College Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9785056044  
Fax    
Email  rntianasif@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr NEHAL ATHREYI R 
Designation  Junior resident 
Affiliation  RNT medical college  
Address  Department of Paediatrics, RNT medical college Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9880012727  
Fax    
Email  nehalathreyi@gmail.com  
 
Source of Monetary or Material Support  
Dr Nehal Athreyi R(Primary sponsor) 
 
Primary Sponsor  
Name  Dr NEHAL ATHREYI R 
Address  Department of Paediatrics, RNT medical college Udaipur Rajasthan 313001 
Type of Sponsor  Other [Primary investigator ] 
 
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 Nehal Athreyi R  RNT medical college  Malnutrition Treatment Centre(MTC) ward, Department of Pediatrics Bal Chikitsalay RNT medical college Near court circle, Udaipur 313001
Udaipur
RAJASTHAN 		 9880012727

nehalathreyi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RNT MEDICAL COLLEGE AND CONTROLLER AND ATTACHED HOSPITALS, UDAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E43||Unspecified severe protein-caloriemalnutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  F-100 diet  It is a standard WHO prescribed diet for SAM patients Composition: Milk Sugar Powdered puffed rice Vegetable oil Water 
Intervention  MENOLLI MALT  The intervention is a new diet formulation which is a mixture containing the following ingredients which are roasted and powdered Contains fourteen ingredients ie. GREEN GRAM FOXTAIL MILLET(KANGNI) MATKI SEED WHEAT BLACK CHANNA JOWAR PEAS FENUGREEK SEEDS PEARL MILLET (BAJRA) SOYA GROUNDNUT SABU DANA BARLEY MAIZE The ingredients are powdered and given at 45g/kg/day mixed with water and jaggery and boiled for 10minutes. The prepared mixture is cooled and given for the child to drink as per demand and daily titration.  
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  5.00 Year(s)
Gender  Both 
Details  All the children registered in MTC ward, whose complication has been managed and are entering the Rehabilitation phase of SAM management 
 
ExclusionCriteria 
Details  1) All those who refuse to consent
2) Critically ill patients
3) Secondary SAM
4) History of food allergy(Gluten, Peanut, etc)
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the effect of a new diet in terms of weight gain per day, designed to supplement the calorie and protein requirements in a SAM child.  Daily monitoring for weight 
 
Secondary Outcome  
Outcome  TimePoints 
To look for the development any intolerance in the form of vomiting, loose stool or sepsis upon supplementation of the new diet.  Daily monitoring for intolerance 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   10/11/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

BACKGROUND:

The cost of F-100, when given at 10ml/kg/2nd hourly amounting to 150ml/kg/day comes to Rupees 6.25/kg/day.

 

The intervention is called ‘MENOLLI MALT’ which is designed using locally available ingredients which is affordable and culturally acceptable by a poor household ie Rupees 3/kg/day.’

 

 

The RDA in a SAM child is as follows:

FLUID

200ml/kg/day

CALORIES

150-220kCal/kg/day

PROTEIN

4-6g/kg/day

 

To provide the above mentioned nutrition in the appropriate quantity, I have designed a new diet which contains fourteen ingredients out of which eleven ingredients can be sprouted, dried, powdered(to enhance the nutritive benefits) and stored.

MONITORING is done by daily weight monitoring and the time taken to achieve discharge criteria

 

 

  

CALORIES 4 (kCal)

PROTEIN4

(g)

COST *

per 100g (Rupees)

Quantity to be added (g)

ADDITIONAL NUTRITIVE VALUE

GREEN GRAM

30

3

9.3

100

 

FOXTAIL MILLET(KANGNI)

376

12

2.4

100

 

MATKI SEED

350

21

4.8

100

 

WHEAT

339

14

6

100

 

BLACK CHANNA

280

20

6

100

selenium

JOWAR

376

12

7

100

 

PEAS

80

7

7

100

 

FENUGREEK SEEDS

333

26

1

10

 

PEARL MILLET (BAJRA)

376

12

7

100

Carotene

SOYA

380

40

9

100

 

GROUNDNUT

567

26

16

100

50g healthy fats

SABU DANA

358

0.2

7

100

 

BARLEY

352

9.9

2

100

 

MAIZE

96

4.5

5

100

 

 

 

 

 

 

 

 

4293

208

90

1310

 

 

 

 

 

 

 

 

 

 

 

 

 

RDA in SAM

 

 

 

 

 

FLUID

200ml/kg/day

 

 

 

 

CALORIES

150-220kCal/kg/day

 

45g powder/kg/day

9 tsp/kg/day

 

PROTEIN

4-6g/kg/day

 

 

 

 

 

 

 

 

 

 

1Tsp=5g Jaggery

17.5kCal

4.4g

 

 

 

15g Jaggery in 100ml water

 

 

 

 

 

 

*COST is estimated by using the local market prices.

 

 

DIET details

Name: MENOLLI MALT

Quantity of each ingredient: 100g (Except Fenugreek= 10g)

Total quantity of the preparation : 1310g

Quantity of the powder required for 1kg child= 45g/day (to provide 150kCal)

Cost of the powder : Rupees 3/kg/day

 

 

 

 

METHOD OF PREPARATION : 100g of each ingredient is taken, they are  sprouted(except Sabu Dana, Barley, Maize), sun dried and ground. Roasting increases the shelf life. Taking 1Tsp=5g, we need about 45g of the powder per kg of the child and hence 9tsp/kg. With fluid requirement being 200ml/kg, we take 250ml water and add 9tsp of the malt powder and 2tsp of Jaggery (for taste and Iron source) and bring to a boil, which will take a maximum of about 10minutes. Then it is cooled and fed at a temperature accepted by the baby.

 

FREQUENCY OF FEED:  The baby can be fed as per demand and the number of feeds titrated according to the quantity of powder required per day.

 

BENEFITS OF THE MALT:

1.         Multinutrient rich including vitamins and trace elements which are mostly deficient in SAM children.

2.         Locally available ingredients

3.         Easy to prepare, requires maximum of 15-20minutes per day.

4.         Good shelf life. Once powder is made, it can b

5.         Low cost: Rupees 3/kg/day. Which on an average amounts to Rupees 450 for a 5kg child per month.

 

Criteria to be fulfilled at the time of discharge- as per NRC protocol

●      return of appetite

●      no episodes of hypoglycaemia (metabolically stable)

●      reduced or disappearance of all oedema

Outcome

●      Discharge

PURPOSE OF THE STUDY

to study if a diet which is prepared using locally available ingredients which is culturally more acceptable is as good as F-100 diet in the management of SAM

 


 
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