5-MTHF Supplementation for Treatment of Type 1 Diabetes Patients

April 8, 2025 updated by: Shanghai Changzheng Hospital

Immunomodulatory and Therapeutic Efficacy of 5-methyltetrahydrofolate Supplementation on Autoimmune Status in Type 1 Diabetes Mellitus

This study aims to evaluate the improvement of autoimmune status in patients with Type 1 Diabetes (T1D) through supplementation with 5-Methyltetrahydrofolate, and to explore the safety and efficacy of this treatment. The research seeks to provide new methods for the treatment of T1D and offer innovative ideas for enhancing the quality of life of T1D patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosed with T1D based on the World Health Organization (WHO) classification criteria for disease diagnosis.
  2. Aged 13-65 years, regardless of gender.
  3. Duration of T1D ≤ 5 years.
  4. Retained residual islet function, defined as fasting C-peptide > 0.1 nmol/L [0.30 ng/mL] or postprandial 2-hour C-peptide > 0.2 nmol/L [0.60 ng/mL].
  5. Determined by the investigator to be capable and willing to: perform self-monitoring of blood glucose (SMBG); complete patient logs as required; receive diabetes education; and comply with the study treatment and visit schedule as per the protocol.

6) Signed informed consent form, with parental/guardian consent and signature required for pediatric/adolescent participants.

Exclusion Criteria:

  1. Serum 5-methyltetrahydrofolate or folate levels exceeding the upper limit of the normal reference range.
  2. Currently experiencing acute metabolic disorders, such as diabetic ketoacidosis or hyperosmolar hyperglycemic state.
  3. Women who are breastfeeding, pregnant, or planning to become pregnant during the trial.
  4. Received immunosuppressive or immunomodulatory therapy within the past year.
  5. Comorbid with other autoimmune diseases, such as systemic lupus erythematosus.
  6. Severe liver, kidney, gastrointestinal, hematologic, cerebral, or circulatory system diseases.
  7. Psychiatric or neurological disorders leading to non-cooperation, non-adherence to medication, substance abuse, or other related issues.
  8. Malignancy.
  9. Recent surgery or significant stress.
  10. Known hypersensitivity or allergic reaction to 5-methyltetrahydrofolate or its excipients.
  11. Investigator's judgment of significant evidence of severe, active, or uncontrolled endocrine or autoimmune abnormalities.
  12. Currently participating in another clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5-MTHF supplementation group
basic diabetes treatment combined with 5-MTHF (5-Methyltetrahydrofolate)
Drug: active folate
Daily oral intake of active folate 800ug combined with basic diabetic treatment
Other Names:
  • 5-Methyltetrahydrofolate
Placebo Comparator: placebo control group
basic diabetes treatment combined with placebo
Drug: Placebo
take oral placebo daily combined with basic diabetic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Islet β cell function
Time Frame: From enrollment to 24 weeks of treatment
Change in the area under curve (0-180min) of the serum C-peptide during the MMTT (Mixed Meal Tolerance Test) at 24 weeks of treatment.
From enrollment to 24 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: From enrollment to 24 weeks of treatment
glycated hemoglobin (HbA1c) <7·0% or ≥ 1% reduction of HbA1c levels from baseline
From enrollment to 24 weeks of treatment
lymphocyte subsets
Time Frame: From enrollment to 24 weeks of treatment
change in lymphocytes subsets
From enrollment to 24 weeks of treatment
islet autoantibodies
Time Frame: From enrollment to 24 weeks of treatment
type and titer of islet autoantibodies
From enrollment to 24 weeks of treatment
insulin dosage
Time Frame: 24 weeks of treatment
change in insulin dosage at 24 weeks of treatment
24 weeks of treatment
cytokines
Time Frame: From enrollment to 24 weeks of treatment
change in serum cytokines
From enrollment to 24 weeks of treatment
CRP
Time Frame: From enrollment to 24 weeks of treatment
change in C-reactive protein
From enrollment to 24 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Changzheng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZYZ-5MTHF-2025-IIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes Mellitus

Clinical Trials on active folate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe