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Main
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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. |
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Register:
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SLCTR |
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Last refreshed on:
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27 April 2013 |
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Main ID: |
SLCTR/2008/017 |
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Date of registration:
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22/08/2008 |
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Primary sponsor: |
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Public title:
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Effect of zinc on sugar control among diabetes
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Scientific title:
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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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Date of first enrolment:
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1/9/2008 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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http://www.slctr.lk/trial_details.asp?reg_id={F3940C26-A57F-405D-BBFF-4A42ABFDCB64} |
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Study type:
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Interventional |
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Study design:
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The diabetic patients will be chosen from patients attending the medical clinics of the Teaching Hospital, Karapitiya
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Countries of recruitment
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Sri Lanka
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Contacts
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Name:
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Dr. ILPR Gunasekara
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Address:
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Coronary Care Unit, Teaching Hospital, Karapitiya, Galle
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Telephone:
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777792787 |
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Email:
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nmu_galle@yahoo.com |
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Affiliation:
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Senior Medical Officer |
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Name:
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Prof. Sarath Lekamwasam
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Address:
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Department of Medicine, Faculty of Medicine, P.O. Box 70, Karapitiya, Galle
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Telephone:
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912234801 |
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Email:
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sarathlk@sltnet.lk |
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Affiliation:
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Professor in Medicine |
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Key inclusion & exclusion criteria
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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:
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus
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Intervention(s)
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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
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Primary Outcome(s)
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Improvement in glycaemic control by multi mineral/vitamin supplementation
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Secondary Outcome(s)
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•Improving awareness on proper blood sugar control among diabetes patients
•Improving awareness on general nutritional status of the diabetes patients
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Source(s) of Monetary Support
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International Atomic Energy Agency (IAEA)
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