Clinical trial NCT00952562: The Influence of Vitamin D on Mineral Metabolism, Blood Pressure and Pulse Wave Analysis in Healthy Individuals
Official title: The Influence of Vitamin D on Mineral Metabolism, Blood Pressure and Pulse Wave Analysis in Healthy Individuals. A Randomised Double Blinded Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: vitamin d
calcium
blood pressure
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: urinary calcium excretion
timeFrame: before and after 16 weeks of intervention
Secondary outcomes:
measure: 25 hydroxyvitamin D
timeFrame: before and after 16 weeks og treatment
measure: 1,25 dihydroxyvitamin D
timeFrame: before and after 16 weeks of treatment
measure: urinary creatinin
timeFrame: before and after 16 weeks of treatment
measure: urinary protein
timeFrame: before and after 16 weeks of treatment
measure: urinary phosphorous
timeFrame: before and after 16 weeks of treatment
measure: p-FGF23
timeFrame: before and after 16 weeks of treatment
measure: blood pressure
timeFrame: before and after 16 weeks of treatment
measure: pulse wave velocity
timeFrame: before and after 16 weeks of treatment
measure: augmentation index
timeFrame: before and after 16 weeks of treatment
measure: central blood pressure
timeFrame: before and after 16 weeks of treatment
measure: p-phosphate
timeFrame: before and after 16 weeks of treatment
measure: ionised p-calcium
timeFrame: before and after 16 weeks of treatment
measure: p-iPTH
timeFrame: before and after 16 weeks of treatment
measure: alkalic phosphatase
timeFrame: before and after 16 weeks of treatment
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Roskilde Hospital
Study officials:
affiliation: Zealand University Hospital
name: Ditte Hansen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zealand University Hospital
name: Niels Erik Frandsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zealand University Hospital
name: Knud Rasmussen, DmSci
role: PRINCIPAL_INVESTIGATOR
affiliation: Zealand University Hospital
name: Lisbet Brandi, DmSci
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for clinical and basic research
name: Hans Christian Hoeck, DmSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.