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Efficacy and safety of vitamin D3 and calcium supplementation for non - infectious uveitis

Efficacy and safety of vitamin D3 and calcium supplementation for non - infectious uveitis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024174
Enrollment
Unknown
Registered
2019-06-29
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-07-01

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

Conditions

Uveitis

Interventions

Group 1:Standard treatment + vitamin D (2000 IU/ D) + calcium (1200 mg/ D)
Group 2:Standard treatment + calcium (1200 mg/d)
Group 3:Standard treatment + vitamin D (2000 IU/ D)
Group 4:Standard treatment

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult male or female >= 18 years old; 2. Diagnosed with intermediate, posterior uveitis or panuveitis in unilateral or bilateral eyes; 3. At least one eye is an active disease and should meet at least one of the following criteria: (1)active inflammatory choroid or retinopathy; (2)anterior chamber cell score >=2+, vitreous opacity score >=2+; 4. Responsive to oral prednisone and immunosuppressive therapy; 5. Oral prednisone dose >=10 mg/d to >=60 mg/d (or equivalent of oral corticosteroids) >= 2 weeks, with no dose change from screening to baseline visit; 6. The primary investigator determined the individual in healthy condition according to medical history, laboratory data, physical examination, chest x-rays, and 12-lead electrocardiogram results taken during screening. 7. Subjects provided sign informed consent; 8. Subjects are willing and able to follow planned visits, treatment plans, laboratory tests and other study procedures.

Exclusion criteria

Exclusion criteria: 1. Confirmed or suspected infectious uveitis, including but not limited to tuberculosis, cytomegalovirus, lyme disease, Toxoplasmosis, an infectious uveitis infection caused by human T lymphocyte virus type 1, herpes zoster disease 2. Intraocular pressure >=25 mmHg and receiving more than 2 glaucoma drugs, or glaucomatous optic nerve injury signs. 3. At baseline, the optimal corrected vision ETDRS of any eye is less than 20 letters; 4. Previous or current anti-tumor necrosis factor (TNF) therapy, or intravitreal anti-intravascular therapy,Skin growth factor (VEGF) therapy, or other forms of biological therapy; 5. Had received intraocular or periocular glucocorticoids within 30 days before baseline; 6. Had received long-acting glucocorticoid implants within 3 years prior to baseline; 7. Had received eye surgery within 90 days prior to baseline; 8. cornea or lens opacification; 9. Severe vitreous opacity; 10. Macular edema caused by non-proliferative, severe diabetic retinopathy or diabetic retinopathy; 11. Wet age-related macular degeneration; 12. Abnormal vitreous retinal interface. 13. Severe infection 14. A history of demyelination diseases. 15. At baseline, the usage of inmmunosuppresive agents except methotrexate, cyclosporin, chlorambucil, mycophenolate mofetil or equivalent, azathioprine, tacrolimus and etcetera. 16. History of moderate to severe congestive heart failure (New York heart association class III or IV). Recent cerebrovascular accidents; 17. History of kidney stones; 18. Previous or present parathyroidism, or hypoparathyroidism; 19. Severe kidney disease, chronic renal failure, or dialysis treatment; 20. Severe liver disease, liver fibrosis; 21. Severe pulmonary disease, grade 3 or 4 (COPD or oxygen-requiring emphysema) 22. Hypercalcemia; 23. Diagnosed with osteoporosis or recommended with the treatment for low bone mass; 24. Two or more low-trauma fractures; 25. Being treated with vitamin D, such as osteomalacia; 26. Masquerade syndrome or malignant tumor, such as eye lymphoma, leukemia, choroid melanoma, etc.; 27. Being infected with hepatitis virus, such as HBsAg positive or hbv-dna positive; 28. History of malignancy in other tissues and organs, past or ongoing treatment for malignancy or malignancy patients with remission less than 5 years; 29. Human immunodeficiency virus (HIV) or syphilis positive individuals during screening; 30. Patients with chronic recurrent infection and active tuberculosis may have a history of invasive infection at the time of screening(e.g., listeriosis, histoplasmosis); 31. Being treated with antituberculosis or preventive treatment for tuberculosis; 32. Addicted to drugs, alcohol or psychotropic substances; 33. Severe mental disorders; 34. Women who are pregnant or lactating are unwilling or unable to use the available access provided in the programme during the study period Women of reproductive age who are subject to contraceptive methods; 35. For any reason, the researchers do not consider suitable for subjects.

Design outcomes

Primary

MeasureTime frame
Time from the randomization of individuals to complete remission of Uvitis;bone mineral density;

Countries

China

Contacts

Public ContactPeizeng Yang

Chongqing Medical University

peizengycmu@126.com+86 13708349782

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026