A Study on Oral Vitamin D Megadoses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ville-Valtteri Välimäki, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01067898
First received: February 11, 2010
Last updated: March 26, 2012
Last verified: March 2012

February 11, 2010
March 26, 2012
February 2010
May 2011   (final data collection date for primary outcome measure)
Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L [ Time Frame: 12 months (including 9 time points) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01067898 on ClinicalTrials.gov Archive Site
  • Decline of creatine clearance (Pt-GFRe-CG) >20% from baseline [ Time Frame: 12 months (including 9 timepoints) ] [ Designated as safety issue: Yes ]
  • Hypercalciuria (dU-Ca >10 mmol/24h) [ Time Frame: 12 months (including 9 timepoints) ] [ Designated as safety issue: Yes ]
  • Hypercalcemia (S-Ca-ion >1,3 mmol/l) [ Time Frame: 12 months (including 9 timepoints) ] [ Designated as safety issue: Yes ]
  • Serum PTH [ Time Frame: 12 months (including 9 timepoints) ] [ Designated as safety issue: No ]
  • Serum PINP [ Time Frame: 12 months (including 5 timepoints) ] [ Designated as safety issue: No ]
  • Serum CTX [ Time Frame: 12 months (including 5 timepoints) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study on Oral Vitamin D Megadoses
A Randomized, Double-blind, Placebo-controlled Study on Oral Vitamin D Megadoses - 100 000 or 200 000 IU Vitamin D3 Every Three Months

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypovitaminosis D
  • Dietary Supplement: vitamin D3 (cholecalciferol)
    vitamin D3 (cholecalciferol) oil 20 000 IU/ml, oral dose of 200 000 IU or 100 000 IU (10ml or 5ml) every three months for one year.
    Other Name: Vigantol vitamin D3 (cholecalciferol) oil 20 000 IU/ml
  • Other: olive oil
    10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year
  • Dietary Supplement: calcium carbonate
    1000 mg calcium per os every day for one year
  • Experimental: 200 000 IU vitamin D3 every three months
    Interventions:
    • Dietary Supplement: vitamin D3 (cholecalciferol)
    • Dietary Supplement: calcium carbonate
  • Experimental: 100 000 IU vitamin D3 every three months
    Interventions:
    • Dietary Supplement: vitamin D3 (cholecalciferol)
    • Other: olive oil
    • Dietary Supplement: calcium carbonate
  • Placebo Comparator: placebo every three months
    Interventions:
    • Other: olive oil
    • Dietary Supplement: calcium carbonate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • female
  • 70-80 yrs old

Exclusion Criteria:

  • disease or medication affecting calcium homeostasis
  • renal failure (Pt-GFRe-CG < 35 ml/min)
Female
70 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01067898
HUS-S-D-II, 2009-018139-98, KLnro 1/2010
No
Ville-Valtteri Välimäki, Helsinki University Central Hospital
Helsinki University Central Hospital
Not Provided
Not Provided
Helsinki University Central Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP