Home » Trials » SLCTR/2022/011
Effect of folic acid supplementation on selected biochemical markers associated with one carbon metabolism and redox amino thiol status in adult type 2 diabetes mellitus patients: A proof of concept double blind randomized clinical trial
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SLCTR Registration Number
SLCTR/2022/011
Date of Registration
The date of last modification
Nov 20, 2024
Scientific Title of Trial
Effect of folic acid supplementation on selected biochemical markers associated with one carbon metabolism and redox amino thiol status in adult type 2 diabetes mellitus patients: A proof of concept double blind randomized clinical trial
Public Title of Trial
Randomized, double blind, placebo controlled, parallel group, proof of concept clinical trial on the effect of low does folic acid supplementation on selected biochemical markers associated with one carbon metabolism and redox amino thiol status in type 2 diabetes mellitus patients.
Disease or Health Condition(s) Studied
Diabetes mellitus(Type 2)
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1272-8744
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
Double blinded : Participants, Investigators, Data analysts, Healthcare providers, Outcome assessors
Control
Placebo
Assignment
Parallel
Purpose
Supportive care
Study Phase
Phase 2
Intervention(s) planned
Placebo tablet will be same in colour, shape, weight, and taste to the test drug and will contain inactive ingredients. Patients will be advised to take one tablet daily 1 hour after breakfast.
The general care they are getting from the relevant diabetes clinics such as medicines, routine medical checkups and consultations are the standard care available to each arm
Inclusion criteria
Exclusion criteria
GFR < 60 mL /min /1.73m2 for >3 months, with or without kidney damage
T2DM patients who are diagnosed with any kind of T2DM complications including Cerebro Vascular Disease, diabetic retinopathy, and neuropathy.
T2DM Patients who are diagnosed with any other diseases (cancer, anemia, and diseases related to hormone disorders).
T2DM patients who have been diagnosed with Diabetes over 5 years.
Subjects who are already undergoing vitamin B12 / Folate supplementation or under any multivitamin which include vitamin B12 and folate.
Pregnant women and Children.
Primary outcome(s)
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1.
• Percentage change (Change in selected biomarkers from baseline. (Homocysteine, cysteine, cysteinyglycine, methionine, Glutathione, SAM, and SAH). Percentage change = Change of plasma concentration of biomarker/plasma concentration of biomarker before folic acid supplementation |
[ Assessment will be done just before the folic acid/placebo intervention (day 1) and just after the 100 days supplementation (day 101). ] |
Secondary outcome(s)
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1.
• Percentage changes in the glycemic levels (FBS and HBA1c levels) Percentage change = Change of plasma concentration of glycemic levels/glycemic levels before folic acid supplementation |
[ Assessment will be done just before the folic acid/placebo intervention (day 1) and just after the 100 days supplementation.(day 101) ] |
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2.
• Percentage changes in the lipid profile (LDL, HDL, Triglyceride, and total Cholesterol) Percentage change = Change of plasma concentration of lipid levels/lipid levels before folic acid supplementation |
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Target number/sample size
200 (100 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2022-08-01
Anticipated end date
2024-04-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
University of Agder, Kristiansand , Norway
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2021-06-29
Approval number
06/21
Details of Ethics Review Committee
| Name: | ERC- university of Sri Jayewardenepura, |
| Institutional Address: | Faculty of Medical Sciences, University of Sri Jayewardenepura, Gangodawila, Nugegoda, Sri Lanka. |
| Telephone: | +94-11-2758588 |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
RS Maddumage
Demonstrator
Department of Basic sciences
Faculty of Allied Health Sciences
General Sir John Kotelawala Defence University,
Werahara,
Sri Lanka
0112635268
+94715459180
ridmimaddumage@gmail.com
Contact Person for Public Queries
Dr. DU Kottahachchi
Dean / Senior Lecturer Gr- I
Faculty of Allied Health Science
General Sir John Kotelawala Defence University
Werahara
Sri Lanka
0112635268
+94718023134
darsha.uda@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
All individual Participant data collected during the trial will be shared after de-identification. Study protocol, and statistical analysis will be available immediately after the publication and up to 5 years. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified and authorized for this purpose, to utilize for further research purpose in an approved proposal. The data may be requested by sending the proposals to the PI.
Study protocol available
No
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
