A Study on Oral Vitamin D Megadoses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ville-Valtteri Välimäki, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01067898
First received: February 11, 2010
Last updated: March 26, 2012
Last verified: March 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Vitamin D Deficiency
Avitaminosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Metabolic Diseases
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 August 21, 2014