| 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
|
|
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. |