Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202005906229512 Date of Approval: 13/05/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title effect of zinc on diabetes
Official scientific title The effect of oral Zinc Supplementation on Glycemic Control in Type 2 Diabetic patients: a single blind randomised controlled trial.
Brief summary describing the background and objectives of the trial Type 2 diabetes mellitus is one of the world’s most prevalent and fatal diseases. Zinc is involved in metabolism of glucose via its participation in insulin crystallization and signaling. This study aimed to evaluate the effect of zinc supplementation on glycemic control in type 2 diabetic patients (primary objective), and to assess adherence to oral hypoglycemic drugs (secondary objective).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/12/2017
Actual trial start date 01/01/2018
Anticipated date of last follow up 02/03/2019
Actual Last follow-up date 30/04/2020
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 195
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group zinc sulphate 25mg 12 weeks The first intervention group received oral capsule of zinc sulphate (25 mg) daily, the second control group was given placebo for 12 weeks in addition to routine oral anti-diabetic drugs. 100
Control Group placebo 0 12 weeks The first intervention group received oral capsule of zinc sulphate (25 mg) daily, the second control group was given placebo for 12 weeks in addition to routine oral anti-diabetic drugs. 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with type 2 diabetes, aged >18 years old, attending the clinic for a routine follow-up visit, on regular use of oral anti-diabetic drugs, with HbAlc concentrations of 7.5-9.5%, who were not enrolled in similar program in the last 6 months, and not taking vitamins or mineral supplements in previous 2 months. severe or uncontrolled cardiovascular disease (defined as a cardiovascular event within the last year), psychiatric disease or cognitive impairment interfering with treatment compliance, pregnancy or lactating women. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/07/2016 faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
4.5 kilo ring road ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome glycated hemoglobin HbA1c before and after 12 weeks
Secondary Outcome body mass index before and after 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
family medicine outpatient clinic in suez canal university hospital 4.5 kilo ring road Ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor suez canal university 4.5 kilo ring road ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator almass hassan almass.fathi@yahoo.com 0201229350414 4.5 kilo ring road
City Postal code Country Position/Affiliation
ismailia Egypt lecturer
Role Name Email Phone Street address
Public Enquiries almass hassan almass.fathi@yahoo.com 0201229350414 4.5 kilo ring road
City Postal code Country Position/Affiliation
ismailia Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries hend salama hind_mikhail@yahoo.com 0201225140752 4.5 kilo ring road
City Postal code Country Position/Affiliation
ismailia Egypt assistant prof
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available, all of the participant data collected during the trial, after deidentification will be shared, the study protocol will be available, immediately after publication ending 3 years after publication to researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to hindmikhail@gmail.com, data requesters will need to sign a data access agreement. Study Protocol immediately after publication ending 3 years after publication researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to hindmikhail@gmail.com, data requesters will need to sign a data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://drive.google.com/drive/my-drive No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information