A Study on Oral Vitamin D Megadoses

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

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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) ]

Eligibility Criteria

• 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)

Contacts and Locations

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 292000 IU of vitamin D (cholecalciferol) on either daily or four monthly basis for elderly women: 1-year comparative study of the effects on serum 25(OH)D concentrations and renal function. Clin Endocrinol (Oxf). 2010 Apr;72(4):455-61. doi: 10.1111/j.1365-2265.2009.03637.x. Epub 2009 May 25.

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
• 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
• 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:

Rickets; Avitaminosis; Vitamin D Deficiency; Deficiency Diseases; Malnutrition; Nutrition Disorders; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Calcium Carbonate; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Bone Density Conservation Agents; Antacids; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents