NCT00952562

Brief Summary

A randomized placebo controlled trial evaluating the effect of the recently recommended high doses of cholecalciferol (3000 IU/day) on mineral metabolism, blood pressure and pulse wave analysis in healthy individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable healthy

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

August 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 24, 2011

Status Verified

August 1, 2011

Enrollment Period

1.8 years

First QC Date

August 3, 2009

Last Update Submit

August 23, 2011

Conditions

Healthy

Keywords

vitamin dcalciumblood pressure

Outcome Measures

Primary Outcomes (1)

  • urinary calcium excretion

    before and after 16 weeks of intervention

Secondary Outcomes (14)

  • 25 hydroxyvitamin D

    before and after 16 weeks og treatment

  • 1,25 dihydroxyvitamin D

    before and after 16 weeks of treatment

  • urinary creatinin

    before and after 16 weeks of treatment

  • urinary protein

    before and after 16 weeks of treatment

  • urinary phosphorous

    before and after 16 weeks of treatment

  • +9 more secondary outcomes

Study Arms (2)

cholecalciferol

ACTIVE COMPARATOR

3000 IU cholecalciferol per day for 16 weeks

Dietary Supplement: cholecalciferol

placebo

PLACEBO COMPARATOR
Dietary Supplement: placebo

Interventions

cholecalciferolDIETARY_SUPPLEMENT

Capsule cholecalciferol 1000 IU, 3 capsules per day for 16 weeks

Also known as: D3-Vitamin
cholecalciferol
placeboDIETARY_SUPPLEMENT

Empty capsules, 3 capsules per day for 16 weeks

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years old
  • p 25OH vitaminD\<50nmol/l
  • signed informed consent

You may not qualify if:

  • receiving antihypertensive or antidiabetic treatment
  • sarcoidoses
  • history of kidney stones
  • receiving 1-alfa-hydroxylated vitamin D treatment
  • plasma creatinin \> 120 micromol/l
  • ionised calcium \> 1,5 mmol/l
  • treatment with calcimimetics
  • active malignancy
  • intestinal malabsorption
  • active pancreatitis
  • former hospitalisation due to alcoholic related disease
  • using euphoriant drugs
  • pregnancy or risk of being pregnant or lactating women
  • Known allergy to cholecalciferol capsules

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roskilde Hospital

Roskilde, Roskilde, 4000, Denmark

Location

Related Publications (2)

  • Bressendorff I, Brandi L, Schou M, Nygaard B, Frandsen NE, Rasmussen K, Odum L, Ostergaard OV, Hansen D. The Effect of High Dose Cholecalciferol on Arterial Stiffness and Peripheral and Central Blood Pressure in Healthy Humans: A Randomized Controlled Trial. PLoS One. 2016 Aug 10;11(8):e0160905. doi: 10.1371/journal.pone.0160905. eCollection 2016.

    PMID: 27509187DERIVED

  • Nygaard B, Frandsen NE, Brandi L, Rasmussen K, Oestergaard OV, Oedum L, Hoeck HC, Hansen D. Effects of high doses of cholecalciferol in normal subjects: a randomized double-blinded, placebo-controlled trial. PLoS One. 2014 Aug 28;9(8):e102965. doi: 10.1371/journal.pone.0102965. eCollection 2014.

    PMID: 25166750DERIVED

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Ditte Hansen, MD

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

  • Niels Erik Frandsen, MD

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

  • Knud Rasmussen, DmSci

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

  • Lisbet Brandi, DmSci

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

  • Hans Christian Hoeck, DmSci

    Center for clinical and basic research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 6, 2009

Study Start

August 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 24, 2011

Record last verified: 2011-08

Locations

DK(1)