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Not yet recruiting NCT06930144

5-MTHF Supplementation for Treatment of Type 1 Diabetes Patients

No phase Interventional Type 1 Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: active folate, Placebo.
Who it may be relevant to
Registry conditions: Type 1 Diabetes Mellitus. Basic parameters: 13 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug active folate
    Daily oral intake of active folate 800ug combined with basic diabetic treatment
  • Drug Placebo
    take oral placebo daily combined with basic diabetic treatment

Primary outcome measures

  • Islet β cell function [Time frame: From enrollment to 24 weeks of treatment]
Secondary outcome measures (6)
  • HbA1c [Time frame: From enrollment to 24 weeks of treatment]
  • lymphocyte subsets [Time frame: From enrollment to 24 weeks of treatment]
  • islet autoantibodies [Time frame: From enrollment to 24 weeks of treatment]
  • insulin dosage [Time frame: 24 weeks of treatment]
  • cytokines [Time frame: From enrollment to 24 weeks of treatment]
  • CRP [Time frame: From enrollment to 24 weeks of treatment]

Eligibility criteria

Inclusion criteria

  • 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 \[0.60 ng/mL\].
  • 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

  • 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.
  • Comorbid with other autoimmune diseases, such as systemic lupus erythematosus.
  • Severe liver, kidney, gastrointestinal, hematologic, cerebral, or circulatory system diseases.
  • Psychiatric or neurological disorders leading to non-cooperation, non-adherence to medication, substance abuse, or other related issues.
  • Malignancy.
  • Recent surgery or significant stress.
  • Known hypersensitivity or allergic reaction to 5-methyltetrahydrofolate or its excipients.
  • Investigator's judgment of significant evidence of severe, active, or uncontrolled endocrine or autoimmune abnormalities.
  • Currently participating in another clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Vukotic R, Di Donato R, Roncarati G, Simoni P, Renzulli M, Gitto S, Schepis F, Villa E, Berzigotti A, Bosch J, Andreone P. 5-MTHF enhances the portal pressure reduction achieved with propranolol in patients with cirrhosis: A randomized placebo-controlled trial. J Hepatol. 2023 Oct;79(4):977-988. doi: 10.1016/j.jhep.2023.06.017. Epub 2023 Jul 22. PMID 37482222
  • Verhaar MC, Wever RM, Kastelein JJ, van Dam T, Koomans HA, Rabelink TJ. 5-methyltetrahydrofolate, the active form of folic acid, restores endothelial function in familial hypercholesterolemia. Circulation. 1998 Jan 27;97(3):237-41. doi: 10.1161/01.cir.97.3.237. PMID 9462523
  • Giammarco S, Chiusolo P, Maggi R, Rossi M, Minnella G, Metafuni E, D'Alo F, Sica S. MTHFR polymorphisms and vitamin B12 deficiency: correlation between mthfr polymorphisms and clinical and laboratory findings. Ann Hematol. 2024 Oct;103(10):3973-3977. doi: 10.1007/s00277-024-05937-z. Epub 2024 Aug 28. PMID 39196375

Identifiers

NCT: NCT06930144 · CZYZ-5MTHF-2025-IIT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗