NCT01067898

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

March 27, 2012

Status Verified

March 1, 2012

Enrollment Period

1.2 years

First QC Date

February 11, 2010

Last Update Submit

March 26, 2012

Conditions

Hypovitaminosis D

Keywords

vitamin D supplementationcholecalciferolPTHbone turnover markerselderly women

Outcome Measures

Primary Outcomes (1)

  • Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L

    12 months (including 9 time points)

Secondary Outcomes (6)

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

    12 months (including 9 timepoints)

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

    12 months (including 9 timepoints)

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

    12 months (including 9 timepoints)

  • Serum PTH

    12 months (including 9 timepoints)

  • Serum PINP

    12 months (including 5 timepoints)

  • +1 more secondary outcomes

Study Arms (3)

200 000 IU vitamin D3 every three months

EXPERIMENTAL
Dietary Supplement: vitamin D3 (cholecalciferol)Dietary Supplement: calcium carbonate

100 000 IU vitamin D3 every three months

EXPERIMENTAL
Dietary Supplement: vitamin D3 (cholecalciferol)Other: olive oilDietary Supplement: calcium carbonate

placebo every three months

PLACEBO COMPARATOR
Other: olive oilDietary Supplement: calcium carbonate

Interventions

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.

Also known as: Vigantol vitamin D3 (cholecalciferol) oil 20 000 IU/ml
100 000 IU vitamin D3 every three months200 000 IU vitamin D3 every three months
olive oilOTHER

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

100 000 IU vitamin D3 every three monthsplacebo every three months
calcium carbonateDIETARY_SUPPLEMENT

1000 mg calcium per os every day for one year

100 000 IU vitamin D3 every three months200 000 IU vitamin D3 every three monthsplacebo every three months

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • female
  • yrs old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Helsinki, FI-00029 HUS, Finland

Location

Related Publications (3)

  • Pekkarinen T, Valimaki VV, Aarum S, Turpeinen U, Hamalainen E, Loyttyniemi E, Valimaki 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.

    PMID: 19486025BACKGROUND

  • Valimaki VV, Loyttyniemi E, Valimaki 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. doi: 10.1038/sj.ejcn.1602550. Epub 2006 Nov 29.

    PMID: 17136043BACKGROUND

  • Valimaki VV, Alfthan H, Lehmuskallio E, Loyttyniemi E, Sahi T, Stenman UH, Suominen H, Valimaki 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. doi: 10.1210/jc.2003-030817.

    PMID: 14715830BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

CholecalciferolOlive OilCalcium Carbonate

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsDietary Fats, UnsaturatedDietary FatsFatsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesCalcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

February 11, 2010

First Posted

February 12, 2010

Study Start

February 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

March 27, 2012

Record last verified: 2012-03

Locations

FI(1)