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

20 May 2022

The date of last modification

Jun 30, 2022



Application Summary


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


Trial Details


What is the research question being addressed?

  1. Does 400 micrograms of daily folic acid supplementation for 100 days in T2DM patients decrease the concentration of plasma total homocysteine?
  2. Does 400 micrograms of daily folic acid supplementation for 100 days in T2DM patients alter the concentration of plasma cysteine, cysteinylglycine, methionine, Glutathione, S-adenosyl methionine (SAM) and S-adenosylhomocysterin (SAH) ?

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

  1. Study setting: Diabetes clinics at Colombo South Teaching Hospital (CSTH ) Sri Lanka and University hospital-General Sir John Kotelawala Defence University ,Werahara, Si Lanka.
  2. Randomization, a) Method of randomization- Simple randomization b) Unit of randomization- Individual patients with type two diabetic mellitus patients c) Method of sequence generation- Sequence will be generated via computer based random number generated software by third party with no clinical involvement in the trial. d) Method of allocation concealment- Concealment of the randomization sequence will be done by using sequentially numbered, opaque sealed envelopes.
  3. Intervention- folic acid Dose- 400µg folic acid, Route- Oral, Duration-100 days, Frequency- 1 tablet per day.
  4. Control – Placebo tablets, Dose- without folic acid, Route- Oral, Frequency- 1 tablet per day

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

  • Subject is a (male or female) between the age of 18 and 60 years.
  • Subject is confirmed as a type 2 Diabetes Mellites without any T2DM related complications.
  • Subjects who have been diagnosed with having T2DM during the past five (5) years.

Exclusion criteria

  • T2DM patients with CKD (1-4 stages) KDOQI criteria of chronic kidney disease diagnosis
  • Kidney damage for >3 months, as defined by structural or functional abnormalities of the kidney, with or without decreased GFR, manifest by either: (Pathological abnormalities; or Markers of kidney damage, including abnormalities in the composition of the blood or urine, or abnormalities in imaging tests)
  • 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)

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)

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)

]
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



State of Ethics Review Approval


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 & Sponsor Information


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

+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

+94718023134

darsha.uda@gmail.com


Primary study sponsor/organization

Department of Medical Laboratory Science (MLS), Faculty of Allied Health sciences (FAHS), General Sir John Kotelawala Defence University (KDU)

General Sir John Kotelawala Defence University Werahara Sri Lanka
0112 635 268


Secondary study sponsor (If any)

Department of Natural Sciences, Faculty of Engineering and Science, University of Agder (UiA), Norway

Campus Kristiansand, Universitetsveien 25, 4630 Kristiansand, Norway
+47 38 14 10 00


Trial Completion details


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