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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: SLCTR
Last refreshed on: 27 April 2013
Main ID:  SLCTR/2008/017
Date of registration: 22/08/2008
Primary sponsor: IAEA research grant SRL 11958
Public title: Effect of zinc on sugar control among diabetes
Scientific title: Zinc status in patients with diabetes mellitus and efficacy of multi mineral supplementation on glycaemic control with special reference to zinc
Date of first enrolment: 1/9/2008
Target sample size: 75
Recruitment status: Completed
URL:  http://www.slctr.lk/trial_details.asp?reg_id={F3940C26-A57F-405D-BBFF-4A42ABFDCB64}
Study type:  Interventional
Study design:  The diabetic patients will be chosen from patients attending the medical clinics of the Teaching Hospital, Karapitiya  
Countries of recruitment
Sri Lanka
Contacts
Name: Dr. ILPR Gunasekara 
Address:  Coronary Care Unit, Teaching Hospital, Karapitiya, Galle
Telephone: 777792787
Email: nmu_galle@yahoo.com
Affiliation:  Senior Medical Officer
Name: Prof. Sarath Lekamwasam 
Address:  Department of Medicine, Faculty of Medicine, P.O. Box 70, Karapitiya, Galle
Telephone: 912234801
Email: sarathlk@sltnet.lk
Affiliation:  Professor in Medicine
Key inclusion & exclusion criteria
Inclusion criteria: 1. not taking vitamin and/or mineral supplements, thyroid hormones, estrogen or progesterone

2. having no history of a recent surgery or acute infection

3. women, not being pregnant or lactating

Exclusion criteria: Diabetes patients who are on insulin preparations as part of diabetic management

Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Diabetes Mellitus
Intervention(s)
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
Primary Outcome(s)
Improvement in glycaemic control by multi mineral/vitamin supplementation
Secondary Outcome(s)
•Improving awareness on proper blood sugar control among diabetes patients

•Improving awareness on general nutritional status of the diabetes patients
Secondary ID(s)
none
Source(s) of Monetary Support
International Atomic Energy Agency (IAEA)
Secondary Sponsor(s)
A. Baur and Co. Ltd
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