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A Study on Oral Vitamin D Megadoses

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ClinicalTrials.gov Identifier: NCT01067898
Recruitment Status : Completed
First Posted : February 12, 2010
Last Update Posted : March 27, 2012
Sponsor:
Information provided by (Responsible Party):
Ville-Valtteri Välimäki, 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.

Condition or disease Intervention/treatment Phase
Hypovitaminosis D Dietary Supplement: vitamin D3 (cholecalciferol) Other: olive oil Dietary Supplement: calcium carbonate Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: 200 000 IU vitamin D3 every three months 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

Dietary Supplement: calcium carbonate
1000 mg calcium per os every day for one year

Experimental: 100 000 IU vitamin D3 every three months 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

Placebo Comparator: placebo every three months 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




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female
  • 70-80 yrs old

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067898


Locations
Finland
Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital
Helsinki, Finland, FI-00029 HUS
Sponsors and Collaborators
Helsinki University Central Hospital

Publications:
Responsible Party: Ville-Valtteri Välimäki, MD,PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01067898     History of Changes
Other Study ID Numbers: HUS-S-D-II
2009-018139-98 ( EudraCT Number )
KLnro 1/2010 ( Other Identifier: The Finnish Medicines Agency Fimea )
First Posted: February 12, 2010    Key Record Dates
Last Update Posted: March 27, 2012
Last Verified: March 2012

Keywords provided by Ville-Valtteri Välimäki, Helsinki University Central Hospital:
vitamin D supplementation
cholecalciferol
PTH
bone turnover markers
elderly women

Additional relevant MeSH terms:
Avitaminosis
Rickets
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcium Carbonate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents