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.: PACTR202006610508575 Date of Approval: 09/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Vitamin C Supplementation on HbA1c in Type 2 Diabetic Patients
Official scientific title Effect of Vitamin C Supplementation on Glycemic Control in Type 2 Diabetic Patients: a Double-blind randomized controlled trial, Egypt.
Brief summary describing the background and objectives of the trial Introduction: Type 2 diabetes mellitus is one of the world’s most prevalent & fatal diseases. Vitamin C is an essential antioxidant which prevents the oxidative stress that was evidenced to be involved in the pathogenesis of type2 diabetes. Some studies investigated the role of vitamin C as a potential adjunct therapy in the management of type 2 diabetes mellitus; the outcomes of such studies were conflicting.this study aims to assess effect of vitamin c suplementation on HA1c in type 2 diabetics
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 01/04/2018
Actual trial start date 20/06/2018
Anticipated date of last follow up 02/01/2019
Actual Last follow-up date 14/11/2019
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 55
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Vitamin c vitamin C 1gm/day for 12 weeks duration received their routine therapy in the form of non-insulin pharmacologic agents with no change in doses or types of their drugs in addition to vitamin C 1gm/day for 12 weeks duration one capsule daily 30
Control Group placebo one capsule daily 12 weeks The placebo contained inulin powder, which is a soluble dietary fiber, a natural polysaccharide, extracted from chicory, and has no effect on blood glucose level. 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Adults with type 2 diabetes (30-60) 2- Diabetics on non-insulin pharmacologic agents. 3- With HbAlc concentrations of >7 % according to glycemic targets in ADA 2020 1- Patients Enrolled in another research study and receiving another modality. 2- Type 1 diabetics and type 2 on insulin. 3- Pregnant or lactating women. 4- Postmenauposal women. 5- Known Severe or uncontrolled cardiovascular disease. 6- Patients with a known history of cognitive impairment interfering with treatment compliance. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 19/07/2017 faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
Ring road kilo 4.5 ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - HbA1c was measured on 12th weeks of the therapy and compared to the pre-intervention level. was measured on 12th weeks of the therapy and compared to the pre intervention level.
Secondary Outcome body mass index at start 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 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dina Hosny 4.5 km on ring road ismailia 41522 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dina hosny Elsaka 4.5 kilo ring road ismailia 41522 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
hend Mikhail Salama 4.5 km ring road ismailia 41522 Egypt
nadia mabrouk mansour 4.5 km ring road ismailia 41522 Egypt
mohamed mohamedy 4.5 km ring road ismailia 41522 Egypt
safwat A ahmed 4.5 km ring road ismailia 41523 Egypt
dina hosny 4.5 km ring road ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator dina elsaka dolcy_1988@yahoo.com +201147545488 4.5 kilo ring road
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer in suez canal university faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries hend salama hind_mikhail@yahoo.com +201276181036 general hospital street
City Postal code Country Position/Affiliation
ismailia 41522 Egypt assistant prof in suez canal university
Role Name Email Phone Street address
Public Enquiries mohammed mohammedy mmohamedy515@gmail.com 01275514525 4.5 kilo ring road
City Postal code Country Position/Affiliation
ismailia 41522 Egypt professor in suez canal university
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 DE identification 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