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5-MTHF Supplementation for Treatment of Type 1 Diabetes Patients | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

5-MTHF Supplementation for Treatment of Type 1 Diabetes Patients

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

NCT06930144•Shanghai Changzheng Hospital

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

13 - 65 years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Key Dates

Start Date

April 1, 2025

Primary Completion Date

April 1, 2026

Completion Date

April 1, 2027

Last Updated

April 16, 2025

Enrollment

ESTIMATED participants

Conditions

Type 1 Diabetes Mellitus

Interventions

active folate

DRUG

Placebo

DRUG

Contacts

Qing Ling, doctor

CONTACT

86+19542790766 lynn_1018@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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5-MTHF Supplementation for Treatment of Type 1 Diabetes Patients

Inclusion Criteria

Exclusion Criteria

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