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Not yet recruitingNCT06930144Updated Apr 16, 2025

5-MTHF Supplementation for Treatment of Type 1 Diabetes Patients

An interventional study of active folate and Placebo in Type 1 Diabetes Mellitus, sponsored by Shanghai Changzheng Hospital. Not yet recruiting. Open to participants aged 13 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-16.

Sponsored by Shanghai Changzheng Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
13 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 1 Diabetes Mellitus
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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 34 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Shanghai Changzheng Hospital is the lead sponsor of 125 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
13 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    5-MTHF supplementation group

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

    Drug: active folate

  • Placebo comparator
    placebo control group

    basic diabetes treatment combined with placebo

    Drug: Placebo

Interventions

  • Drugactive folate

    Daily oral intake of active folate 800ug combined with basic diabetic treatment

    Also known as: 5-Methyltetrahydrofolate

  • DrugPlacebo

    take oral placebo daily combined with basic diabetic treatment

06

What researchers measure

Primary outcomes

  1. Islet β cell function

    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.

    Time frame: From enrollment to 24 weeks of treatment

Secondary outcomes

  1. HbA1c

    glycated hemoglobin (HbA1c) \<7·0% or ≥ 1% reduction of HbA1c levels from baseline

    Time frame: From enrollment to 24 weeks of treatment

  2. lymphocyte subsets

    change in lymphocytes subsets

    Time frame: From enrollment to 24 weeks of treatment

  3. islet autoantibodies

    type and titer of islet autoantibodies

    Time frame: From enrollment to 24 weeks of treatment

  4. insulin dosage

    change in insulin dosage at 24 weeks of treatment

    Time frame: 24 weeks of treatment

  5. cytokines

    change in serum cytokines

    Time frame: From enrollment to 24 weeks of treatment

  6. CRP

    change in C-reactive protein

    Time frame: From enrollment to 24 weeks of treatment

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 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. PubMed 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. PubMed 39196375 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06930144
Lead sponsor
Shanghai Changzheng Hospital
Responsible party
Sponsor
First posted
Apr 16, 2025
Start date
Apr 2025 (estimated)
Primary completion
Apr 2026 (estimated)
Completion
Apr 2027 (estimated)
Last update
Apr 16, 2025

Study contacts

Qing Ling, doctor
Contact
lynn_1018@126.com
86+19542790766

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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