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Effect of Alfacalciferol on prevention and treatment of steroid associated bone disease and urinary protein in children with nephrotic syndrome

Clinical study on the prevention and treatment strategy of alfacalciferol on hormone-related bone disease in children with nephrotic syndrome

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055790
Enrollment
Unknown
Registered
2022-01-19
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Nephrotic syndrome

Interventions

Treatment group:Vitamin D calcium+ a- Calciferol
control group:Vitamin D calcium

Sponsors

Guangzhou women and children's medical center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1. Male or female subjects at the age of 1 to 18 years, informed consent is required; 2. The diagnosis of primary nephrotic syndrome requires systemic glucocorticoid therapy; 3. No history of glucocorticoid use within 6 months before screening; 4. No history of using calcium, vitamin D and vitamin D derivatives within the 6 months before screening; 5. No history of fracture; 6. Before screening, dual-energy X-ray bone mineral density determination of lumbar spine and radius bone mineral density Z score >= -1.0SD; 7. Normal range of blood calcium and blood phosphorus before screening; 8. Height HtSDS >= -2.0 before screening; 9. Children with normal liver and kidney function; 10. Children with normal blood pressure.

Exclusion criteria

Exclusion criteria: 1. Refractory hypercalcemia 2. Refractory hypertension 3. Progressive decline in liver and kidney function 4. Severe infection 5. Complicated with malignant tumors, abnormal thyroid function and abnormal parathyroid function 6. Adverse reactions to the drug intolerance 7. People undergoing renal replacement therapy due to medical conditions

Design outcomes

Primary

MeasureTime frame
bone density;Cumulative dose of glucocorticoid;

Secondary

MeasureTime frame
Early biomarkers of bone metabolism;

Countries

China

Contacts

Public ContactLiao Xin

Guangzhou women and children's medical center

lyckon@sina.com+86 13822148504

Outcome results

None listed

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