A Study on Oral Vitamin D Megadoses

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 4

Conditions: Hypovitaminosis D

Treatments: Other: olive oil; Dietary Supplement: calcium carbonate; Dietary Supplement: vitamin D3 (cholecalciferol)

Study type: Interventional

Funder types: Other

Identifiers

NCT01067898

2009-018139-98 (EudraCT Number)

KLnro 1/2010 (Other Identifier)

HUS-S-D-II

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 70+ years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

200 000 IU vitamin D3 every three months

Experimental group

Treatment:

Dietary Supplement: calcium carbonate

Dietary Supplement: vitamin D3 (cholecalciferol)

100 000 IU vitamin D3 every three months

Experimental group

Treatment:

Dietary Supplement: calcium carbonate

Other: olive oil

Dietary Supplement: vitamin D3 (cholecalciferol)

placebo every three months

Placebo Comparator group

Treatment:

Dietary Supplement: calcium carbonate

Other: olive oil