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The Impact of Correcting Nutritional Vitamin D Deficiency and Bone Mineral Metabolism Disorders on Complications in Hemodialysis

The Impact of Correcting Nutritional Vitamin D Deficiency and Bone Mineral Metabolism Disorders on Complications in Hemodialysis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099025
Enrollment
Unknown
Registered
2025-03-18
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Uremia Maintenance Hemodialysis

Interventions

Traditional Treatment Group:Correcting hyperphosphatemia with calcium containing or non calcium containing phosphate binders, and controlling secondary hyperparathyroidism with cinacalcet hydrochlorid
New treatment group:On the basis of traditional treatment, an additional 800IU of vitamin D3 capsules were taken orally daily, and 60mg of denosumab was injected subcutaneously every 6 months for a to

Sponsors

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 75 years, gender unrestricted. 2. Diagnosis of CKD stage 5 according to the 2012 KDIGO guidelines (eGFR<=15 ml/(ml/min/1.73m²)); 3. Receiving regular hemodialysis treatment 2-3 times per week, each session lasting 4 hours, for more than 3 months. 4. Serum parathyroid hormone (iPTH) = 400 pg/ml, and dual-energy X-ray absorptiometry (DXA) indicates bone mass reduction or osteoporosis. 5.Signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who have severe bleeding tendency and active bleeding, or have clear coagulation dysfunction; 2. Lactating or pregnant women or those who plan to become pregnant within one year; 3. Those who have undergone parathyroidectomy within 1 year; 4. History of infection, malignant tumor, active rheumatic immune disease; 5. Patients with an expected survival of less than one year; 6. As judged by the investigator, the patient has other conditions that are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Vascular Calcification Score;

Secondary

MeasureTime frame
AAAAll-cause death;

Countries

China

Contacts

Public ContactYang Guang

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)

13512515730@163.com+86 135 1251 5730

Outcome results

None listed

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