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Evaluation of serum Vitamin D levels in patients with Polycystic kidney disease.

Serum vitamin D levels in Autosomal Dominant Polycystic Kidney Disease (ADPKD)patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4x92fr
Enrollment
Unknown
Registered
2016-12-08
Start date
2011-08-08
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

Polycystic Kidney Disease, Vitamin D deficiency, hypertension

Interventions

A seventy-four (74) adult patients evaluated at the Nephrology Division from Universidade Federal de São Paulo, who had received a diagnosis of ADPKD were selected to participate in the present study.
Magister Handling Pharmacy Ltd., São Paulo, Brazil) and it was given to these patients by the principal researcher (by o
Other
C18.654.521.500.133.770
C12.777.419.403

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: Volunteeers with Autosomal Dominant Polycystic Kidney Disease; both genders; aged between 18 to 75 years; normo or hypertensives; vitamin D deficient [25(OH) < 30ng/ml).

Exclusion criteria

Exclusion criteria: Age 10 mg/dL; serum phosphorous > 5,5 mg/dL; pregnancy; bowel disease; malignances; current/past use of vitamin D or calcium supplements.

Design outcomes

Primary

MeasureTime frame
Beneficial effect of vitamin D3 supplementation on lowering blood pressure and inflammatory markers. The parameters of blood pressure were assessed by ambulatory blood pressure monitoring(ABPM)in baseline period and after 3 months of supplementation. It is was expected that systolic and diastolic blood pressure would lower after vitamin D3 supplementation. With respect to inflammatory markers (Interleukin 6 and 10, tumor necrosis factor alpha, factor nuclear kappa B) that were evaluated in blood samples, it was expected a decrease in these levels after vitamin D3 supplementation. It was also expected that the expression of vitamin D receptor (VDR), vitamin D regulatory enzymes (CYP27B1 and CYP24A1)would increase after supplementation and serum levels of vitamin D [25(OH)D] would achieve levels above 30 ng/ml. ;Fourty-six patients (46) presented hypovitaminosis D [25(OH)< 30 ng/ml], being randomized in vitamin D3 or placebo group. Vitamin D3 supplementation restored serum levels of vitamin D to above 30 ng/ml in 16 patients (76%). There was found no differences in blood pressure parameters (systolic and diastolic), inflammatory markers and in the expression of vitamin D receptor (VDR) and the ezymes CYP27B1 and CYP24A1 after vitamin D3 supplementation.

Secondary

MeasureTime frame
Beneficial effect of sufficient serum levels of vitamin D (> 30ng/ml) upon hipertension, inflammatory markers and renal volume. It was expected a negative correlation between serum levels of vitamin D [25(OH)D] or its receptor (VDR) with inflammatory markers, evaluated in blood sample, blood pressure parameters assessed by ambulatory monitoring blood pressure (ABPM)and renal volume determined by resonance magnetic imaging. ;Serum vitamina D levels [25(OH)D] and VDR expression were not negatively correlated with blood pressure parameters. Serum vitamin D levels [25(OH)D] and VDR expression were negatively correlated with renal volume. Vitamin D receptor (VDR) was negatively correlated with inflammatory markers (IL-6, IL-10, C reactive protein and nuclear factor kappa B.

Countries

Brazil

Contacts

Public ContactPablo Ferraz

Universidade Federal de São Paulo

pablo.ferraz@unifesp.br+55115904-1681

Outcome results

None listed

Source: REBEC (via WHO ICTRP)