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

Effects of supplementation with vitamin D3 in the cardiovascular system in patients with chronic kidney disease in predialysis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-95j5pm
Enrollment
Unknown
Registered
2012-01-30
Start date
2011-04-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D deficiency, Chronic kidney failure.

Interventions

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 Outcome
dietary supplement

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Age
18 Years to 75 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactRoberta Pillar

Universidade Federal de Sao Paulo

robipillar@hotmail.com011 59048499

Outcome results

None listed

Source: REBEC (via WHO ICTRP)