Value Antiproteinuric Effects From Vitamin D Derivatives in Patient With Chronic Kidney Illness and the Lack of Vitamin D
NCT ID: NCT01442272
Last Updated: 2012-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
174 participants
INTERVENTIONAL
2012-01-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Habitual medication withuot additional
Habitual medication
Habitual medication
Habitual medication plus Hidroferol®
Hidroferol®
Hidroferol® drinkable ampoule in oral solution, 266 mcg (1 drinkable ampoule) each 15 days during 12 months
Habitual medication plus Zemplar®
Paricalcitol: Zemplar®
Paricalcitol (Zemplar®) oral capsule , 1 mcg (1 capsule)each 24 hours during 12 months
Interventions
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Hidroferol®
Hidroferol® drinkable ampoule in oral solution, 266 mcg (1 drinkable ampoule) each 15 days during 12 months
Paricalcitol: Zemplar®
Paricalcitol (Zemplar®) oral capsule , 1 mcg (1 capsule)each 24 hours during 12 months
Habitual medication
Habitual medication
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients have signed written informed consent
* Chronic Kidney Illness phase II-IV plus residual proteinuria \>0,5 grams/day (two or more consecutive occasions) and plus beta blockers treatment from AARS during al least 3 months.
* Serum levels of calcifediol in the lack of level (15-30 ng/ml).
Exclusion Criteria
* Bad control of diabetes (HbA1c higher 9,5 in the last three months period)
* Hypercalcemia (\<10,2 mg/dL) o hyperphosphatemia(\>5,5 mg/dL), CaxPO4\>50, hypercalciuria (urin Ca/Cr quotient \> 0,15)
* Vitamin D treatment or any analogous
* Hepatic failure ( AST o ALT \> 3 times higher than normal limit)
* medical history of poor nutrient intestinal absorptions or chronic diarrhea
* Active nephrolithiasis
* Treatment with medication wich can change vitamin D metabolism (phenobarbital, phenytoin, rifampicin)
* Participation in other Clinic Trial in 3 last months
* Active Alcoholism
* Neoplasia precedent (except cutaneous no melanoma)
* Pregnant women or while breastfeeding
* Vitamin D hypersensitivity or any its excipient hypersensitivity
* Any other condition from Research
18 Years
ALL
No
Sponsors
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Hospital Universitario de Canarias
OTHER
Responsible Party
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Locations
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Hospital Universitario de Canarias
San Cristóbal de La Laguna, S/C Tenerife, Spain
HUC
San Cristóbal de La Laguna, S/c Tenerife, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NEFROVID2010
Identifier Type: -
Identifier Source: org_study_id
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