Effect of Vitamin D Supplement on Osteoprotegin Expression and Disease Progression in Patients With Chronic Kidney Disease Stage 1 and 2

Taixing People's Hospital

Status and phase: Unknown; Phase 4

Conditions: Chronic Kidney Disease Stage 2; Chronic Kidney Disease Stage 1

Treatments: Drug: Calcitriol; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01561222

zhangxu2012

Details and patient eligibility

About

Vitamin D Supplement in patients with CKD stage 1 and 2 may change osteoprotegin expression so as to produce beneficial effects of cardiovascular、bone metabolism and CKD progression.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of CKD stage 1 and 2
• Age >18 years
• Ability to provide informed consent

Exclusion criteria

• On vitamin D in past 4 weeks
• Plans to relocate out of Taixing City in the next one year
• Serum phosphate >5.5 mg/dl in past 3 months
• Serum calcium >10.0 mg/dl in past 3 months
• Cancer
• Transplanted organ
• Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Treatment:

Drug: placebo

Calcitriol

Experimental group

Treatment:

Drug: Calcitriol