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5-Methyltetrahydrofolate Supplementation for Autoimmune Status in Type 1 Diabetes

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What is being tested

active folate

+ Placebo

Drug
Who is being recruted

Autoimmune Diseases+5

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 1

From 13 to 65 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorShanghai Changzheng Hospital
Study ContactQing Ling, doctor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on exploring whether a supplement called 5-Methyltetrahydrofolate can improve the autoimmune status of people with Type 1 Diabetes. Type 1 Diabetes is a condition where the body's immune system mistakenly attacks the insulin-producing cells in the pancreas. The study aims to see if this supplement can help manage the condition better and improve patients' quality of life. By investigating this, researchers hope to find new treatments and provide innovative options for those living with Type 1 Diabetes. Participants in the study will receive the 5-Methyltetrahydrofolate supplement, and researchers will monitor their health to assess the safety and effectiveness of the treatment. The study will evaluate changes in the autoimmune status of the participants to determine if the supplement is beneficial. While potential benefits include better management of Type 1 Diabetes, the study also aims to ensure that the treatment is safe for patients to use. The results could offer valuable insights into new ways of improving care for those affected by this condition.

Official TitleImmunomodulatory and Therapeutic Efficacy of 5-methyltetrahydrofolate Supplementation on Autoimmune Status in Type 1 Diabetes Mellitus
NCT06930144
Principal SponsorShanghai Changzheng Hospital
Study ContactQing Ling, doctor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

34 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 13 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDiabetes MellitusDiabetes Mellitus, Type 1Endocrine System DiseasesImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

6 inclusion criteria required to participate
Diagnosed with T1D based on the World Health Organization (WHO) classification criteria for disease diagnosis.
Aged 13-65 years, regardless of gender.
Duration of T1D ≤ 5 years.
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].
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12 exclusion criteria prevent from participating
Serum 5-methyltetrahydrofolate or folate levels exceeding the upper limit of the normal reference range.
Currently experiencing acute metabolic disorders, such as diabetic ketoacidosis or hyperosmolar hyperglycemic state.
Women who are breastfeeding, pregnant, or planning to become pregnant during the trial.
Received immunosuppressive or immunomodulatory therapy within the past year.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
basic diabetes treatment combined with 5-MTHF (5-Methyltetrahydrofolate)

Group II

Placebo
basic diabetes treatment combined with placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
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