A Study on Oral Vitamin D Megadoses - Full Text View

Purpose

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	Intervention	Phase
Hypovitaminosis D	Dietary Supplement: vitamin D3 (cholecalciferol) Other: olive oil Dietary Supplement: calcium carbonate	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary hypophosphatemic rickets

MedlinePlus related topics: Calcium Rickets Vitamin D

Drug Information available for: Cholecalciferol Calcium Gluconate Calcium carbonate Vitamin D Olive oil

U.S. FDA Resources

Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:

Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L [ Time Frame: 12 months (including 9 time points) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Decline of creatine clearance (Pt-GFRe-CG) >20% from baseline [ Time Frame: 12 months (including 9 timepoints) ] [ Designated as safety issue: Yes ]
Hypercalciuria (dU-Ca >10 mmol/24h) [ Time Frame: 12 months (including 9 timepoints) ] [ Designated as safety issue: Yes ]
Hypercalcemia (S-Ca-ion >1,3 mmol/l) [ Time Frame: 12 months (including 9 timepoints) ] [ Designated as safety issue: Yes ]
Serum PTH [ Time Frame: 12 months (including 9 timepoints) ] [ Designated as safety issue: No ]
Serum PINP [ Time Frame: 12 months (including 5 timepoints) ] [ Designated as safety issue: No ]
Serum CTX [ Time Frame: 12 months (including 5 timepoints) ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	February 2010
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	70 Years and older
Genders 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications:

Pekkarinen T, Välimäki VV, Aarum S, Turpeinen U, Hämäläinen E, Löyttyniemi E, Välimäki MJ. The same annual dose of 292 000 IU of vitamin D(3) (cholecalciferol) on either daily or four monthly basis for elderly women: 1-year comparative study of the effects on serum 25(OH)D(3) concentrations and renal function. Clin Endocrinol (Oxf). 2009 May 25; [Epub ahead of print]

Välimäki VV, Löyttyniemi E, Välimäki 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. Epub 2006 Nov 29.

Välimäki VV, Alfthan H, Lehmuskallio E, Löyttyniemi E, Sahi T, Stenman UH, Suominen H, Välimäki 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.

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, KLnro 1/2010
Study First Received:	February 11, 2010
Last Updated:	March 26, 2012
Health Authority:	Finland: Finnish Medicines Agency Finland: Ethics Committee

Keywords provided by Helsinki University Central Hospital:

vitamin D supplementation
cholecalciferol
PTH
bone turnover markers
elderly women

Additional relevant MeSH terms:

Rickets
Avitaminosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcium Carbonate

Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 23, 2013