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Completed

NCT Number: NCT01067898

A Study on Oral Vitamin D Megadoses

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.

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Key information

Conditions

Hypovitaminosis D Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

70 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

Helsinki, FI-00029 HUS, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female
  • 70-80 yrs old

Exclusion criteria

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

Treatment and study plan

vitamin D3 (cholecalciferol)

Dietary Supplement

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 names: Vigantol vitamin D3 (cholecalciferol) oil 20 000 IU/ml

olive oil

Other

10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year

Calcium Carbonate

Dietary Supplement

1000 mg calcium per os every day for one year

Primary outcomes

  1. 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

  1. Decline of creatine clearance (Pt-GFRe-CG) >20% from baseline

    Time frame: 12 months (including 9 timepoints)

  2. Hypercalciuria (dU-Ca >10 mmol/24h)

    Time frame: 12 months (including 9 timepoints)

  3. Hypercalcemia (S-Ca-ion >1,3 mmol/l)

    Time frame: 12 months (including 9 timepoints)

  4. Serum PTH

    Time frame: 12 months (including 9 timepoints)

  5. Serum PINP

    Time frame: 12 months (including 5 timepoints)

  6. Serum CTX

    Time frame: 12 months (including 5 timepoints)

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 12, 2010
Registry last updated
Mar 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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