The aim of this study is evaluation of the effects of nicotinic acid on hyperphosphatemia in dialysis patients of Valiasr-Arak center.
Hyperphosphatemia is one of the most common metabolic disorders in end-stage renal disease patients that is independent risk factor for cardiovascular disease. It has been shwon that correction of Hyperphosphatemia decreases left ventricular hypertrophy. Bone fracture, chronic arthralgia , diffuse itching, fatigue, generalized , anxiety are also other effects of Hyperphosphatemia that affect quality of life.
Low dietary intake of phosphate is not enough to control Hyperphosphatemia and needs extra medication to reduce dietary phosphate absorption.
Nicotinic acid or vit B3 has been used as a drug for Hyperphosphatemia. Currently the most common indication for niacin or nicotinic acid is decreasing triglyceride and increasing HDL. The most important side effect of niacin is vasodilation and hot flush, that is due to prostaglandin production and is controllable with aspirin.
GI discomfort such as cramps and diarrhea are other niacin side effects.
At 2004, nicotinic acid was used to reduce serum phosphorous. Nicotinic acid inhibits phosphorous handling and intestinal absorption.
Now a days, many clinical trials established effects of nicotinic acid in dialysis patients to control Hyperphosphatemia.
This clinical trial is a prospective study with case and control group in hemodialysis patients in Valiasr-Arak center to evaluate effects of niacin on serum phosphorous.
After obtaining informed consent, patients will be randomly classified in two groups. Group I will receive nicotinic acid and group II will receive placebo.
Nicotinic acid will be started as 400 mg/day, patients will be controlled for nicotinic acid's side effects such as GI problems and thrombocytopenia. Calcium & phosphorous will be checked every other week. If serum calcium and phosphorous is greater than 4 mg/day, nicotinic acid will be increased to 600 mg/day (200 mg additional).
If phosphorous is lesser than 3.5 mg/day, nicotinic acid will be reduced to 200 mg/day. If serum phosphorous is between 3.5 – 4 mg/day, it will remain unchanged. Nicotinic acid will continue till 8 weeks. Two weeks later, case and control groups will change place with regard to the reception of nicotinic acid and placebo. Now group II will receive nicotinic acid for 8 weeks.
In addition to calcium and phosphorous, CBC, PTH, lipid profile will be checked at 0-8-18 weeks.
This way, we will evaluate nicotinic acid effects on serum phosphorous in dialysis patients.
During the study, dialysis protocol of patients will remain unchanged and dialysis efficacy will be evaluated by BUN & creatinine before and after hemodialysis. Binding drugs to phosphorous and Vit D will be continued as before.
Inclusion criteria: Age > 18&<90 years, sign satisfaction, serum phosphorous: 5-7 mg/day, unchanged treatment protocol, (calcium components and Vit D) during last two weeks, unchanged dialysis protocol.
Exclusion criteria: pregnancy, known liver disease, active peptic ulcer, carbamazepine use, drug intolerance.