NCT06930144

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 13 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2025-04-16
• Last updated: 2025-04-16