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
|
|
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
|
|
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. |