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A Study on Oral Vitamin D Megadoses

Primary Purpose

Hypovitaminosis D

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
vitamin D3 (cholecalciferol)
olive oil
calcium carbonate
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypovitaminosis D focused on measuring vitamin D supplementation, cholecalciferol, PTH, bone turnover markers, elderly women

Eligibility Criteria

70 Years - undefined (Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • female
  • 70-80 yrs old

Exclusion Criteria:

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

Sites / Locations

  • Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

200 000 IU vitamin D3 every three months

100 000 IU vitamin D3 every three months

placebo every three months

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 11, 2010
Last Updated
March 26, 2012
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01067898
Brief Title
A Study on Oral Vitamin D Megadoses
Official Title
A Randomized, Double-blind, Placebo-controlled Study on Oral Vitamin D Megadoses - 100 000 or 200 000 IU Vitamin D3 Every Three Months
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovitaminosis D
Keywords
vitamin D supplementation, cholecalciferol, PTH, bone turnover markers, elderly women

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
200 000 IU vitamin D3 every three months
Arm Type
Experimental
Arm Title
100 000 IU vitamin D3 every three months
Arm Type
Experimental
Arm Title
placebo every three months
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3 (cholecalciferol)
Other Intervention Name(s)
Vigantol vitamin D3 (cholecalciferol) oil 20 000 IU/ml
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
olive oil
Intervention Description
10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year
Intervention Type
Dietary Supplement
Intervention Name(s)
calcium carbonate
Intervention Description
1000 mg calcium per os every day for one year
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Decline of creatine clearance (Pt-GFRe-CG) >20% from baseline
Time Frame
12 months (including 9 timepoints)
Title
Hypercalciuria (dU-Ca >10 mmol/24h)
Time Frame
12 months (including 9 timepoints)
Title
Hypercalcemia (S-Ca-ion >1,3 mmol/l)
Time Frame
12 months (including 9 timepoints)
Title
Serum PTH
Time Frame
12 months (including 9 timepoints)
Title
Serum PINP
Time Frame
12 months (including 5 timepoints)
Title
Serum CTX
Time Frame
12 months (including 5 timepoints)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: female 70-80 yrs old Exclusion Criteria: disease or medication affecting calcium homeostasis renal failure (Pt-GFRe-CG < 35 ml/min)
Facility Information:
Facility Name
Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
FI-00029 HUS
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19486025
Citation
Pekkarinen T, Valimaki VV, Aarum S, Turpeinen U, Hamalainen E, Loyttyniemi E, Valimaki MJ. The same annual dose of 292000 IU of vitamin D (cholecalciferol) on either daily or four monthly basis for elderly women: 1-year comparative study of the effects on serum 25(OH)D concentrations and renal function. Clin Endocrinol (Oxf). 2010 Apr;72(4):455-61. doi: 10.1111/j.1365-2265.2009.03637.x. Epub 2009 May 25.
Results Reference
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PubMed Identifier
17136043
Citation
Valimaki VV, Loyttyniemi E, Valimaki MJ. Vitamin D fortification of milk products does not resolve hypovitaminosis D in young Finnish men. Eur J Clin Nutr. 2007 Apr;61(4):493-7. doi: 10.1038/sj.ejcn.1602550. Epub 2006 Nov 29.
Results Reference
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PubMed Identifier
14715830
Citation
Valimaki VV, Alfthan H, Lehmuskallio E, Loyttyniemi E, Sahi T, Stenman UH, Suominen H, Valimaki MJ. Vitamin D status as a determinant of peak bone mass in young Finnish men. J Clin Endocrinol Metab. 2004 Jan;89(1):76-80. doi: 10.1210/jc.2003-030817.
Results Reference
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A Study on Oral Vitamin D Megadoses

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