| CTRI Number |
CTRI/2010/091/001396 [Registered on: 19/01/2011] |
| Last Modified On: |
15/07/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Other (Specify) [Food Supplement] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
Modification(s)
|
Oral Nutritional Supplementation in Hospital Patients |
Scientific Title of Study
Modification(s)
|
Oral Nutritional Supplementation in Hospital Patients |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| BK83 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Not applicable |
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
DrVinita Satyavrat |
| Designation |
|
| Affiliation |
Head MedicalANI |
| Address |
Abbott Nutrition International-India
11th FloorHallmark Plaza
Sant Dyaneshwar Marg
Near Gurunanak Hospital
Mumbai
MAHARASHTRA
400 051
India |
| Phone |
02267566010 |
| Fax |
02267566060 |
| Email |
vinita.satyavrat@abbott.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dilip Nair Manager CRO |
| Designation |
|
| Affiliation |
|
| Address |
Abbott Health Care Pvt. Ltd
11th Floor, Hallmark Plaza Sant Dyaneshwar Marg
Near Gurunanak Hospital
Mumbai
MAHARASHTRA
400 051
India |
| Phone |
02267566015 |
| Fax |
02267566060 |
| Email |
dilip.nair@abbott.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Abbott Nutrition, Abbott Laboratories
Research & Development and Scientific Affairs
625 Cleveland Avenue, Columbus, OH 43215-1724
|
|
Primary Sponsor
Modification(s)
|
| Name |
Abbott Nutrition |
| Address |
Abbott Laboratories Research & Development and Scientific Affairs625 Cleveland Avenue, Columbus, OH 43215-1724 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Abbott Healthcare Pvt Ltd |
11th Floor, Hall Mark Plaza Near Gurunanak Hospital Bandra (East) Mumbai,400051, India |
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Subhash Todi |
1. Advanced Medicare and Research Institute |
Gariahat Road (Beside Dhakuria Bridge),-700 029
Kolkata
WEST BENGAL |
.+91-9831202040
91-33-2440-4803
drsubhashtodi@gmail.com |
| Dr.Ravindra Reddy |
2. Care Hospital- Hyderabad |
Banjara Hills,-500034
Hyderabad
ANDHRA PRADESH |
040 3041 8888
040 6662 8222
drbravinderreddy@yahoo.com |
| Dr.Kayanoosh Kadapatti |
3. Jehangir Clinical Development Centre Pvt. Ltd |
Jehangir Hospital, ,32, Sassoon Road-411001
Pune
MAHARASHTRA |
+91-20-26059318
+91-20-26059319
drkayanoosh@gmail.com |
| DrDeepak Talwar |
4. Metro Multispecialty Hospital |
X-1,Sector -12, Noida 201301
Ghaziabad
UTTAR PRADESH |
91-120-2533491
91-0120-2533487
dtlung@hotmail.com |
| Dr.Renuka Munshi |
5. TN Medical College & BYL Nair Hospital |
Dr.A.L.Nair Road, ,Mumbai Central,-400 008
Mumbai
MAHARASHTRA |
+91 22 2302 7204
+91 22 2305 0347
renuka.munshi@gmail.com |
| Dr.Shiva Iyer |
6. Sahyadri Hospitals Limited |
30C, Erandawane,Karve Road-411 004
Pune
MAHARASHTRA |
+91 20 6721 3000
+91 20 2545 9117
suchetashiva@gmail.com |
| Dr.Nirmala Rege |
7. Seth GS Medical College and KEM Hospital |
1st floor, Dept of pharmacology,,Parel-400 012
Mumbai
MAHARASHTRA |
+91 22 24136051
+91 22 2412 1711
nimarege@gmail.com |
| Dr Sudhir Kumar Bhatnagar |
Abhinav Multispeciality Hospital |
Kamal Chowk, Nagpur 440017
Maharashtra India
Nagpur
MAHARASHTRA |
91-9823148978
drsudhirbhatnagar@gmail.com |
| Dr Parshant Aggarwal |
Dayanand Medical College and Hospital |
Civil Lines,Ludhiana 141001,
Punjab,India
Ludhiana
PUNJAB |
91-815532533
dparshant@yahoo.com |
| Dr.Sudhir R.Pawar |
Lokmanya Thilak Muncipal Medical College & General Hospital |
Dr.Ambedkar Road,Sion-400 022
Mumbai
MAHARASHTRA |
+91-22-24076381(Ext: 285)
spawar5@yahoo.com |
| Dr Shantanu Sengupta |
Sengupta Hospital and Research Institute |
Ravinagar Square,Nagpur - 44003,Maharashtra,India
Nagpur
MAHARASHTRA |
91-9923190925
senguptasp@gmail.com |
| Dr Atul Gogia |
Sir Ganga Ram Hospital |
Old Rajender Nagar New Delhi 110060 India
New Delhi
DELHI |
91-9891003450
atulgogs@rediffmail.com |
| Dr Vikram Sharma |
St.Theresas Hospital |
Erragadda,Sanath Nagar
Hyderabad 500018
Hyderabad
ANDHRA PRADESH |
91-9866960555
drvikramsharma@gmail.com |
| Dr B L N Prsad Professor of Medicine |
Unit - VI Department of Medicine |
Unit VI Department of Medicine
King George Hospital Andhra Medical College
Visakhapatnam 530002
Andhra Pradesh India
Visakhapatnam
ANDHRA PRADESH |
91-9848211931
mcmedicine@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Care Institutional Ethical Committee |
Approved |
| Drug Trial Ethics Committee, DMC & Hospital |
Approved |
| Ethics Committee for Research on Human Subjects Seth G.S. Medical College & K.E.M Hospital, Mumbai |
Approved |
| Ethics Committee St Theresa Hospital |
Approved |
| Ethics Committee, B.Y.L. Nair Charitable Hospital & T.N. Medical College, Mumbai |
Approved |
| Ethics Committee, Metro Hospital, Noida |
Approved |
| Ethics Committee, Sahyadri Hospital, Pune |
Approved |
| EthicsCommitteeSir GangaRamHospital |
Approved |
| Hospital Ethics Committee, Advanced Medicare & Research Institute Ltd., Kolkata |
Approved |
| Independent Ethics Committee |
Approved |
| Institutional Ethics Committee, King George Hospital, |
Approved |
| Jehangir Clinical Development Centre, Ethics Committee ,Pune |
Approved |
| Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital, Staff & Research Society, L.T.M. Medical College Building, 2nd Floor, Room-17, Sion, Mumbai 400 022 |
Approved |
| Nagpur Independent Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
To evaluate the benefits of ONS plus Dietary Counseling (DC) in newly admitted hospital subjects with moderate or severe malnutrition.
, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Dietary Counseling (DC) |
12 weeks |
| Intervention |
Oral Nutritional Supplementation (ONS) + Dietary Counseling (DC) |
12 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Subject
1.Is greater than or equal 18 years of age
2.Is recently admitted into hospital less than or equal to 36 hrs.
3.Identified as having moderate malnutrition or severe malnutrition.
4.Has anticipated length of hospital stay of at least 3 days.
5.Has a life expectancy of grater than or equal to 12 weeks
6.Is able to consume foods and beverages orally.
7.Is willing to abstain from additional non-study provided protein supplements or nutritional supplements throughout the study period
|
|
| ExclusionCriteria |
| Details |
Subject
1.has alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, dysphagia, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances, in the opinion of the Study Physician, at study entry.
2.has a diagnosis of diabetes, burn injury covering greater than or equal to 15% of the body, advanced renal or hepatic disease (including cirrhosis), active malignancy, including melanoma and excluding cutaneous malignancies (e.g., basal cell carcinoma, squamous cell carcinoma and carcinoma of the cervix).
3.has clinically significant ascites, pleural effusion, severe edema or dehydration as determined by a physician.
4.Severe edema is defined as Stage 4.
5.is currently taking medications/ supplements/substances that could profoundly modulate metabolism or weight (e.g. diuretics, appetite stimulants, progestational agents, steroids, growth hormone, dronabinol, marijuana, or other anabolic agents).
6.Exceptions: Inhaled steroids for asthma or chronic obstructive pulmonary disease will be allowed. Topical or optical steroids will also be allowed. In addition, stable doses of steroids or diuretics taken for greater than or equal to 6 weeks prior to hospitalization and maintains the stable dosage for the duration of the study will be allowed.
7.has active tuberculosis, acute Hepatitis B or C, or HIV (per documentation in the medical record).
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Body Weight |
at base line, weeks 4, 8 and12 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Nutrition Assessment,BMI and Blood Chemistries |
Nutrition Assessment and BMI at baseline and week 12 and Blood Chemistries at baseline and weeks 4,8,12 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="212"
Sample Size from India="212"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
09/11/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not available now |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Study Objective: To evaluate the benefits of ONS plus Dietary Counseling (DC) in newly admitted hospital subjects with moderate or severe malnutrition. Number of Subjects / Length of Participation : Approximately 212 subjects (men and women) from multiple Institutions in India will participate in this study. The duration for subject evaluation is 12 weeks. Expected total duration for the study is approximately 9 months. Study Design : Prospective, controlled, randomized, parallel-design, multi-center trial Eligible subjects will be randomized into 2 treatment groups 1.Dietary Counseling only (n=106) 2.Dietary Counseling + ONS (n=106). Primary Outcome : Change in body weight from baseline Secondary Outcomes : Subjective Global Assessment (values and change from baseline) Body Mass Index (values and changes from baseline) Blood chemistries (values and changes from baseline) |