5-MTHF Supplementation for Treatment of Type 1 Diabetes Patients
NCT ID: NCT06930144
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
34 participants
INTERVENTIONAL
2025-04-30
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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5-MTHF supplementation group
basic diabetes treatment combined with 5-MTHF (5-Methyltetrahydrofolate)
active folate
Daily oral intake of active folate 800ug combined with basic diabetic treatment
placebo control group
basic diabetes treatment combined with placebo
Placebo
take oral placebo daily combined with basic diabetic treatment
Interventions
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active folate
Daily oral intake of active folate 800ug combined with basic diabetic treatment
Placebo
take oral placebo daily combined with basic diabetic treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
13 Years
65 Years
ALL
No
Sponsors
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Shanghai Changzheng Hospital
OTHER
Responsible Party
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Central Contacts
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References
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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.
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.
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.
Other Identifiers
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CZYZ-5MTHF-2025-IIT
Identifier Type: -
Identifier Source: org_study_id
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