The Influence of Vitamin D on Mineral Metabolism, Blood Pressure and Pulse Wave Analysis in Healthy Individuals

Zealand University Hospital

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: cholecalciferol; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00952562

7. juli 2009, version 1

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

cholecalciferol

Active Comparator group

Description:

3000 IU cholecalciferol per day for 16 weeks

Treatment:

Dietary Supplement: cholecalciferol

placebo

Placebo Comparator group

Treatment:

Dietary Supplement: placebo