Vitamin D Deficiency Clinical Trial
Official title:
Randomized Clinical Trial for The Evaluation of The Effects Of Cholecalciferol Supplementation On The Parathyroid Hormone In Hemodialysis Patients
Introduction. Vitamin D regulates mineral metabolism. Its deficiency has been associated with
diabetes, cancer and increased mortality. 25OH vitamin D (25VD) is stable and suitable for
the evaluation of vitamin D sufficiency.
The aim of the study is to evaluate whether cholecalciferol supplementation for a period of
12 weeks can normalize decreased 25VD levels and reduce increased parathormone (iPTH) in
hemodialysis (HD) patients with a vitamin D deficiency. Secondary aims: to evaluate decrease
in inflammation, anemia or use of erythropoietin.
Design. Randomized, double blind clinical trial in two arms of HD patients with 25OH Vitamin
D deficiency and secondary hyperparathyroidism, for a period of 12 weeks.
Population. Patients over 18 years of age on HD for more than 3 months and levels of 25VD <
30 ng / ml and iPTH >300 ng/ml , who sign a consent form. Randomization will be achieved by
using a table of random numbers at the pharmacy, and neither doctors nor patients will know
which group they have been assigned to.
Treatment. Supplementation will consist of one 5000 IU cholecalciferol tablet or placebo
during dialysis for a period of 12 weeks.
Monthly monitoring will include: haemoglobin (g/dl), Calcium (mg/dl), Phosphorous (mg/dl),
PTH (ng/ml), epo dose (IU/kg/week), epo resistance (IU/kg/week/g Hb).
At the beginning and end of the study the following will be measured: alkaline Phosphatase
(IU/ml), PCR (mg/L), 25VD (ng/ml), ferritin (ng/ml) and transferrin saturation, quality of
life (SF36).
During the study, doses of calcitrol or paricalcitol will not be modified. The study will be
discontinued if calcemia ≥ 10.5 mg/dL is detected on two occasions.
Size of sample is estimated at 120 patients for a PTH decrease of 20% in 35% of patients in
group treated (assuming 15% follow-up losses). Analysis will be done for Intention to treat
for the primary outcome.
Ethical aspects: Authorization has been obtained from the Ethics Committee of the institution
as regards Good Clinical Practices, Helsinki Declaration and national regulations. The trial
will be registered at the Ministry of Health.
Introduction. Vitamin D regulates mineral metabolism. Its deficiency has been associated with
diabetes, cancer and increased mortality. 25OH vitamin D (25VD) is stable and suitable for
the evaluation of vitamin D sufficiency.
The aim of the study is to evaluate whether cholecalciferol supplementation for a period of
12 weeks can normalize decreased levels of 25VD and reduce increased parathormone (iPTH) in
hemodialysis (HD) patients with a vitamin D deficiency. Secondary aims: to evaluate decrease
in inflammation, anemia or use of erythropoietin (epo).
Design. Randomized, double blind clinical trial in two arms of HD patients with 25VD
deficiency and secondary hyperparathyroidism, one arm to be treated with cholecalciferol
supplementation and the other with a placebo, for a period of 12 weeks.
Population. Patients over 18 years of age on HD for more than 3 months and levels of 25VD <
30 ng / ml and iPTH >300 ng/ml , who sign a consent form. Once their consent has been
obtained, iPTH and 25VD levels will be measured. Randomization will be achieved by using a
table of random numbers at the pharmacy, and neither doctors nor patients will know which
group they have been assigned to.
Treatment. Supplementation will consist of three 5000 IU cholecalciferol tablets or placebo
postdialysis per week during dialysis for a period of 12 weeks.
Monthly monitoring will include: haemoglobin (g/dl), Calcium (mg/dl), Phosphorous (mg/dl),
iPTH (ng/ml), epo dose (IU/kg/week), epo resistance (IU/kg/week/g Hb).
At the beginning and end of the study the following will be measured: alkaline Phosphatase
(IU/ml), C reactive protein (mg/L), 25VD (ng/ml), ferritin (ng/ml) and transferrin
saturation, quality of life (SF36).
During the study, doses of calcitrol or paricalcitol will not be modified. The study will be
discontinued if calcemia ≥ 10.5 mg/dL is detected on two occasions.
Size of sample is estimated at 120 patients for a iPTH decrease of 20% in 35% of patients in
group treated (assuming 15% follow-up losses). Analysis will be done for Intention to treat
for the primary outcome.
Ethical aspects: Authorization has been obtained from the Ethics Committee of the institution
as regards Good Clinical Practices, Helsinki Declaration and national regulations. The trial
was registered at the Ministry of Health.
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