| CTRI Number |
CTRI/2018/07/014815 [Registered on: 11/07/2018] Trial Registered Prospectively |
| Last Modified On: |
25/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dietary supplement and exercise] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study in inter relations of physical activity, nutrient intake and muscle function in rural Indian children. |
|
Scientific Title of Study
|
Studies in inter relations of physical activity, nutrient intake and muscle function in rural Indian children. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anuradha Khadilkar |
| Designation |
Deputy Director |
| Affiliation |
Hirabai Cowasji Jehangir Medical Research Institute |
| Address |
Hirabai Cowasji Jehangir Medical Research Institute, Lower ground floor, Jehangir Hospital, 32, Sassoon Road, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
09850244305 |
| Fax |
020-26141340 |
| Email |
anuradhavkhadilkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha Khadilkar |
| Designation |
Deputy Director |
| Affiliation |
Hirabai Cowasji Jehangir Medical Research Institute |
| Address |
Hirabai Cowasji Jehangir Medical Research Institute, Lower ground floor, Jehangir Hospital, 32, Sassoon Road, Pune
MAHARASHTRA
411001
India |
| Phone |
09850244305 |
| Fax |
020-26141340 |
| Email |
anuradhavkhadilkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravindra Ghooi |
| Designation |
Chairperson |
| Affiliation |
Ethics Committee Jehangir Clinical Development Centre Pvt. Ltd. |
| Address |
Ethics Committee Jehangir Clinical Development Centre Pvt. Ltd.,
Jehangir Hospital premises, 32, Sassoon Road, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
09922918967 |
| Fax |
|
| Email |
ravindra.ghooi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hirabai Cowasji Jehangir Medical Research Institute |
|
|
Primary Sponsor
|
| Name |
Hirabai Cowasji Jehangir Medical Research Institute |
| Address |
Lower ground floor, Jehangir hospital, 32, Sassoon Road,Pune 411001 |
| Type of Sponsor |
Research institution |
|
|
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 Anuradha Khadilkar |
Hirabai Cowasji Jehangir Medical Research Institute |
Lower Ground Floor, 32
Sassoon Road,
Jehangir Hospital
Premise, Pune
Pune
MAHARASHTRA |
020-26141340
anuradhavkhadilkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Jehangir Clinical Development Centre Pvt. Ltd. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To improve muscle function parameters in children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nutritional supplement |
A specially formulated nutritional supplement (Laddoo and savoury puri), rich in protein to be given for a period of 6 months (180 days), 5 days a week. |
| Intervention |
Nutritional supplement and exercise module 1 |
A specially formulated nutritional supplement, rich in protein (Laddoo or savoury puri) to be given orally, 5 days a week in addition to a specially designed exercise module focusing on increasing strength of the muscles to be performed 3 days a week for 30 minutes, for a period of 6 months (180 days). |
| Intervention |
Nutritional supplement and exercise module 2 |
A specially formulated nutritional supplement, rich in protein (Laddoo or savoury puri) to be given orally, 5 days a week in addition to a specially designed exercise module focusing on increasing agility and flexibility of the muscles to be performed 3 days a week for 30 minutes, for a period of 6 months (180 days). |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Healthy, physically active children, aged 6-10 years, from rural schools in Pune district |
|
| ExclusionCriteria |
| Details |
Children with height or weight below 3rd percentile or above 97th percentile according to Indian reference charts recommended by the Indian Academy of Pediatrics
Those who are severely anaemic (i.e. Hb<8g/dl)
Use of any drug known to affect bone or muscle health
Children who have received Vitamin D supplements previously
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A possible increase in the muscle function parameters (muscle force and muscle power). The muscle force and muscle power will be assessed using ground reaction force plates. |
After 6 months of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study may help in identifying which type of activity has the maximum positive effect on muscle function in children and thus help in planning sports curriculum in schools. |
At endline,that is 6 months after intervention. |
|
|
Target Sample Size
|
Total Sample Size="225"
Sample Size from India="225"
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)
|
30/07/2018 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of the study is to study the effects of different types of exercises along with
protein and energy supplementation on muscle function parameters assessed using
jumping mechanography in rural Indian school children. Short-term interventions involving moderate-intensity physical activity,
including school-based programs, can improve aerobic fitness and lower the
degree of adiposity. Weight-bearing activities during childhood
have a positive effect on bone strength and low bone strength in childhood is
associated with a higher fracture risk in later life. Increased dietary protein combined
with progressive resistance training can enhance muscle mass, size, and
strength, particularly in young- and middle-aged adults. However,
such data is scarce in paediatric population. Also, whether exercise combined
with protein supplementation can promote a greater
response than either exercise or protein alone has not been investigated. We hypothesize that supplementation with these nutrients along with regular and structured exercise will improve the muscle function parameters in children. This, in
turn, will improve their health and performance and general well-being. This study may also help in
identifying which type of activity has the maximum positive effect on muscle
function in children and thus help in planning sports curriculum in schools. |