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Multicenter, prospective, randomized, double-blind, placebo-controlled clinical study of the efficacy of vitamin D2 injection in patients with type 2 diabetes with distal symmetrical polyneuropathy

Multicenter, prospective, randomized, double-blind, placebo-controlled clinical study of the efficacy of vitamin D2 injection in patients with type 2 diabetes with distal symmetrical polyneuropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062266
Enrollment
Unknown
Registered
2022-07-31
Start date
2022-07-31
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

Sponsors

Longyan First Hospital Affiliated to Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. People diagnosed with type 2 diabetes according to the 1999 diagnostic criteria of the World Health Organization; 2. No gender limit, aged 18-79 years; 3. Voluntarily participate in the study, sign the informed consent and comply with the study protocol; 4. According to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes 2020 Edition, the five-item physical examination was consistent with the clinical diagnosis of distal symmetrical polyneuropathy.

Exclusion criteria

Exclusion criteria: 1. Have been treated with vitamin D2 injection within one month recently; 2. Allergic to vitamin D medications; 3. Parathyroid disease; 4. Alcohol or drug abusers; 5. Patients with hyperthyroidism or hypothyroidism; 6. Severe disability or mental illness; 7. Pregnant and lactating patients; 8. Those who plan long-term outdoor activities and frequent life in tropical areas; 9. Patients with blood calcium level exceeding 11mg/dl(2.75mmol/l), history of urinary tract calculi and sarcoidosis; 10. Stress diseases such as shortness of breath, acute chest pain, fever, diarrhea and other acute inflammation, severe leukopenia, malignant tumor, liver insufficiency (bilirubin >1.5 times the upper limit of normal value, alanine aminotransferase > 2 times the upper limit of normal value) or renal function decline eGFR10 mg/d glucocorticoid drugs; Renal rickets; 11. The patients were judged by the investigator to be unfit to participate in this study.

Design outcomes

Primary

MeasureTime frame
25 hydroxyvitamin D;Michigan neuropathy screening insrtument;

Secondary

MeasureTime frame
Toronto clinical scoring system,TCSS;Fasting plasma glucose;Postprandial blood glucose;Glycosylated hemoglobin;Fasting C-peptide;Fasting insulin;Total cholesterol;Triglycerides;High-density lipoprotein cholesterol;Low-density lipoprotein cholesterol;Systolic blood pressure;Diastolic blood pressure;Body mass index;Serum calcium;Uric acid;

Countries

China

Contacts

Public ContactChen Tao

Longyan First Hospital Affiliated to Fujian Medical University

citycreek@163.com+86 13859206278

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026