With calcium carbonate as the positive control drug, to observe the effectiveness and safety of nicotinic acid in hemodialysis patients with hyperphosphatemia
Hyperphosphatemia is an important risk factor affecting long-term survival in patients with hemodialysis. Nicotinic acids, as well as its metabolites nicotinamide, were found to inhibit the sodium-phosphorus co-transporter on animal intestines. Several studies from other countries demonstrated that nicotinamide can reduce blood phosphorus levels in end-stage kidney disease patients. The purpose of this study was to investigate the effectiveness and safety of nicotinic acids on hyperphosphatemia in hemodialysis patients of ethnic Han live in China. The study is a prospective, randomized, double-blind, placebo-controlled crossover study. Eligible patients will be randomized to 6 wk of nicotinic acids or calcium carbonate. After a 2-wk washout period, patients switched to 6 wk of the alternative therapy. The primary measurement is the change in serum phosphorus during the whole term of each arm. Statistical analysis will be performed using two-sample paired-group t test.The significance level of the analysis was set to 0.05. All other adverse reactions will be analysed and reported, if there.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
45
Nicotinic acids is administered at an initial dosage of 50mg four times daily in the first week. If no significant side effects detected, the dosage will be titrated to 100mg five times daily within the second week and last to the end of study.
Calcium Carbonate 500mg per oral, twice a day
Jiujiang NO.1 People's Hospital
Jiujiang, Jiangxi, China
RECRUITINGchange in serum phosphorus
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in serum calcium
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in serum calcium-phosphorus product
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in intact parathyroid hormone
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in alkaline phosphatase
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in platelet count
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in serum uric acid
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in serum glucose
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in total cholesterol
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in triglyceride
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in high density lipoprotein cholesterol
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Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in low density lipoprotein cholesterol
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in serum glutamic-pyruvic transaminase
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in glutamic oxalacetic transaminase
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in bilirubin
Time frame: Immediately after wash-out period and after 6 weeks of therapy.