A Randomized, Double-blind, Placebo-controlled Study on Oral Vitamin D Megadoses - 100 000 or 200 000 IU Vitamin D3 Every Three Months

Helsinki University Central Hospital1 site in 1 country60 target enrollmentFebruary 2010

ConditionsHypovitaminosis D

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Hypovitaminosis D
Sponsor: Helsinki University Central Hospital
Enrollment: 60
Locations: 1
Primary Endpoint: Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if infrequent administration of oral vitamin D megadoses is effective treatment to maintain serum 25-hydroxyvitamin D(3) above target levels of 50-75 nmol/L. The investigators hypothesize that 100 000 IU or at least 200 000 IU vitamin D3 in every three months would be effective and safe treatment to achieve the target levels.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

May 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Helsinki University Central Hospital

Responsible Party

Principal Investigator

Ville-Valtteri Välimäki

MD,PhD

Helsinki University Central Hospital

Eligibility Criteria

Inclusion Criteria

•70-80 yrs old

Exclusion Criteria

•disease or medication affecting calcium homeostasis
•renal failure (Pt-GFRe-CG \< 35 ml/min)

Outcomes

Primary Outcomes

Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L

Time Frame: 12 months (including 9 time points)

Secondary Outcomes

Decline of creatine clearance (Pt-GFRe-CG) >20% from baseline(12 months (including 9 timepoints))
Hypercalciuria (dU-Ca >10 mmol/24h)(12 months (including 9 timepoints))
Hypercalcemia (S-Ca-ion >1,3 mmol/l)(12 months (including 9 timepoints))
Serum PTH(12 months (including 9 timepoints))
Serum PINP(12 months (including 5 timepoints))
Serum CTX(12 months (including 5 timepoints))