Home » Trials » SLCTR/2008/017
Zinc status in patients with diabetes mellitus and efficacy of multi mineral supplementation on glycaemic control with special reference to zinc
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SLCTR Registration Number
SLCTR/2008/017
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Zinc status in patients with diabetes mellitus and efficacy of multi mineral supplementation on glycaemic control with special reference to zinc
Public Title of Trial
Effect of zinc on sugar control among diabetes
Disease or Health Condition(s) Studied
Diabetes Mellitus
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
The diabetic patients will be chosen from patients attending the medical clinics of the Teaching Hospital, Karapitiya 1. Diabetes patients will be stratified by sex, age and duration of treatment and randomly assigned to one of three treatment groups 2. Group A will be supplemented with oral zinc sulfate (22mg of elemental zinc/day) and multivitamin/mineral preparation (vitamin A, Vitamin D3, Vitamin E, magnesium, manganese, copper and selenium) 3. Group B will be supplemented with same preparation but without zinc 4. Group C will be supplemented with placebo and designed as a control group 5.Depending upon the treatment groups, each subject will receive one tablet per day for a period of 4 months 6. A questionnaire on social demography will be administered and 24 hour dietary intake will be recorded 7. Their anthropometry and blood pressure will be recorded 8. Following investigations will be done at the study entry and at the end of the follow-up Fasting blood sugar a.Post prandial blood sugar b.HbA1c c.Serum creatinine d.Serum zinc e.Urinary zinc f.Urinary creatinine
Inclusion criteria
Exclusion criteria
Diabetes patients who are on insulin preparations as part of diabetic management
Primary outcome(s)
|
1.
Improvement in glycaemic control by multi mineral/vitamin supplementation |
[ At the end of the study: June 2009 ] |
Secondary outcome(s)
|
1.
•Improving awareness on proper blood sugar control among diabetes patients •Improving awareness on general nutritional status of the diabetes patients |
[ Throughout the research programme i.e., July 2008 to June 2009 ] |
Target number/sample size
75
Countries of recruitment
Sri Lanka
Anticipated start date
2008-09-01
Anticipated end date
2009-04-30
Date of first enrollment
2008-12-01
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
International Atomic Energy Agency (IAEA)
Regulatory approvals
Status
Approved
Date of Approval
2008-04-01
Approval number
Not Available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Prof. Sarath Lekamwasam
Professor in Medicine
Department of Medicine, Faculty of Medicine, P.O. Box 70, Karapitiya, Galle
912234801
912222314
sarathlk@sltnet.lk
Contact Person for Public Queries
Dr. ILPR Gunasekara
Senior Medical Officer
Coronary Care Unit, Teaching Hospital, Karapitiya, Galle
777792787
912222314
nmu_galle@yahoo.com
Primary study sponsor/organization
A. Baur & Co. Ltd
Healthcare Division, 62, Jethawana Road, Colombo 14
114728784
112473258
nalindra@baurs.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
