The effects of nicotinic acid on hyperphosphatemia in dialysis patients of valiasr-Arak center

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT138812153492N1
• Prospective Registration: Yes
• Primary sponsor: Depuity of education & research of Arak university of Medical science
• Public title: The effects of nicotinic acid on hyperphosphatemia in dialysis patients of valiasr-Arak center
• Scientific title: The effects of nicotinic acid on hyperphosphatemia in dialysis patients of valiasr-Arak center
• Date of first enrolment: 2010-02-20
• Target sample size: 30
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/3603
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment.
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Fatemeh Zameni
• Affiliation: Arak University of medical science

• Name: Mahnaz Edalat-Nejad
• Affiliation: Arak medical science university

Key inclusion & exclusion criteria

Inclusion criteria: 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.
Exclusion criteria:

Age minimum: 18 years
Age maximum: 90 years
Gender: Both

Health Condition(s) or Problem(s) studied

disorder of phosphorus metabolism

Hyperphosphatemia.
disorder of phosphorus metabolism

Intervention(s)

Intervention 1: Placebo. Intervention 2: Intervention group (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.

Intervention group (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.

Placebo

Treatment - Drugs

Primary Outcome(s)

Serum phosphate level. Timepoint: Twice a weeks for 4 months. Method of measurement: by pars azmon kit in Valiasr Hospital.

Secondary Outcome(s)

Serum calcium level. Timepoint: Twice a week for 4 mounths. Method of measurement: by pars kit in valiasr hospital.

HDL Level. Timepoint: 0-2-4 month. Method of measurement: Pars Azmoon kit in Valiasr Hospital Lab.

Source(s) of Monetary Support

Depuity of education & research of Arak university of Medical science

Ethics review

Status: Approved
Approval date:
Contact:

Ethics committee of Arak university of medical science