A Study on Oral Vitamin D Megadoses

Phase 4

Completed

• Conditions: Hypovitaminosis D
• Interventions: Dietary Supplement: vitamin D3 (cholecalciferol); Dietary Supplement: calcium carbonate; Other: olive oil

• Registration Number: NCT01067898
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-11
• Study First Submitted QC: 2010-02-11
• Study First Posted: 2010-02-12
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-26
• Last Update Posted: 2012-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• female
• 70-80 yrs old

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
100 000 IU vitamin D3 every three months	vitamin D3 (cholecalciferol)	-
200 000 IU vitamin D3 every three months	vitamin D3 (cholecalciferol)	-
200 000 IU vitamin D3 every three months	calcium carbonate	-
100 000 IU vitamin D3 every three months	olive oil	-
100 000 IU vitamin D3 every three months	calcium carbonate	-
placebo every three months	olive oil	-
placebo every three months	calcium carbonate	-

Primary Outcome Measures

Name	Time	Method
Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L	12 months (including 9 time points)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland