Effects of supplementation with vitamin D in patients with chronic kidney disease

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-95j5pm
• Date of registration: 30/01/2012
• Primary sponsor: Universidade Federal de São Paulo - São Paulo, SP, Brazil
• Public title: Effects of supplementation with vitamin D in patients with chronic kidney disease
• Scientific title: Effects of supplementation with vitamin D3 in the cardiovascular system in patients with chronic kidney disease in predialysis
• Date of first enrolment: 20/04/2011
• Target sample size: 80
• Recruitment status: recruitment completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-95j5pm/
• Study design: Preventive, parallel,double-blind, three arms,randomized clinical trial.

Countries of recruitment

Brazil

Contacts

• Name: Roberta Pillar
• Affiliation: Universidade Federal de Sao Paulo

• Name: Roberta Pillar
• Affiliation: Universidade Federal de Sao Paulo

Key inclusion & exclusion criteria

Inclusion criteria: Patients in stages 3 and 4 CKD (creatinine clearance between 59 and 15 mL/min/1.73m ²); Both genders; Aged between 18 and 75 years; Patients in the conservative treatment of CKD for at least 3 months; With serum 25 (OH) D3 <30 ng/mL: And who agree to participate.
Exclusion criteria: Patients with nephrotic syndrome, liver disease, neoplastic, autoimmune or infectious activity and were seropositive for HIV;
Patients who received any supplements or vitamin D analogues, corticosteroids and immunosuppressive drugs in the last 3 months;
Patients with hypercalcemia (ionized calcium> 1.40 mmol/L) and/or serum parathormone (PTH) levels> 500 pg/mL; Patients immobilized in the last three months.


Age minimum: 18Y
Age maximum: 75Y
Gender: -

Health Condition(s) or Problem(s) studied

E00-E90

Vitamin D deficiency, Chronic kidney failure.
C18.654.521.500.133.770
C12.777.419.780.750.500

Intervention(s)

80 patients will be included and suplementation with vitamin D3 (cholecalciferol) will follow the guidelines of clinical practice guide from the National Kidney Foundation (NFK) Kidney Disease Outcomes Quality Initiative (K / DOQI).According to the serum 25(OH)D3, participants will be divided into 2 groups: insufficient group [25(OH)D3 serum between 30-15 ng/mL) and deficient group [25(OH)D3 <15ng/mL].The insufficient group will be randomized to 2 groups (study group and control group).The study group will receive supplementation with vitamin D3 (cholecalciferol 50.000IU/month orally for 6 months).After 6 months, there will be new measure of 25(OH)D and maintenance dose until study completion (18 months).The control group will use placebo which has the shape, smell, taste like, without having the active drug.The deficient group [25(OH)D3 serum <15 ng/mL] must be treated . The participants with serum 25 (OH) D3 less than 5 will receive 50.000IU cholecalciferol/week orally for 12 weeks and followed monthly for 6 months.After 6 months, will be made measure of 25(OH)D levels with supplementation and maintenance according to serum 25(OH)D.Participants with serum levels of 25(OH)D between 5-15 will receive cholecalciferol 50.000IU/week for 4 weeks, then 50.000IU/month orally for 6 months, with measured levels of 25(OH)D and maintenance according to serum 25(OH)D.

Primary Outcome(s)

Beneficial effect of vitamin D3 supplementation on the cardiovascular system. The cardiovascular parameters will be assessed by ambulatory blood pressure monitoring(ABPM) and helical computed tomography coronary carried out at the beginning and end of the study. It is hope that with suplementation reduce blood pressure levels, both systolic and diastolic.Regarding calcification is expected to occur coronary plaque stabilization or even regression. About the laboratory tests is expected to decrease PTH values, increase the values of 25(OH)D above 30ng/mL, and calcium values remain in the normal range.

Secondary Outcome(s)

Beneficial effect of vitamin D3 supplementation in control of the secondary hyperparathyroidism in chronic kidney disease. Evaluation will be performed by laboratoy tests of total and ionized calcium, serum phosphorus and PTH-intact.About the laboratory tests is expected to decrease PTH values, increase the values of 25(OH)D above 30ng/mL, and calcium values remain in the normal range.

Supplementation with vitamin D3 is expected to control secondary hyperparathyroidism, as assessed by laboratory tests of PTH-intact. About the PTHi, is expected to decrease yours values.It is also expected to present that there is no causal relationship between supplementation and hypercalcemia. Laboratory tests will be collected monthly until the sixth month of supplementation, after six months every two months.It is expected that the values calcium ??remain in normal range.

Secondary ID(s)

415/2008

Source(s) of Monetary Support

CNPq - Brazil

Secondary Sponsor(s)

Universidade Federal de São Paulo - São Paulo, SP, Brazil