The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors

NCT ID: NCT02750293

Last Updated: 2017-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 411 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-09-30

Brief Summary

Six-hundred subjects with vitamin D deficiency will be randomized to vitamin D 3000 IU per day versus placebo for 4 months, with effects on cardiovascular risk factors as main endpoint

Detailed Description

Vitamin D is a hormone with effects not only on the skeleton, but on most tissues in the body. Lack of vitamin D is associated with cardio-vascular disease (CVD) and type 2 diabetes, and also with risk factors for these diseases like hypertension, dyslipidemia, insulin resistance, and endothelial dysfunction. However, intervention studies with vitamin D have been inconclusive regarding diseases and risk factors. Most of these studies were done in white, Western populations in subjects fairly vitamin D sufficient, and accordingly, no benefits were to be expected. Also, in many studies the doses of vitamin D have been too low, and the studies underpowered. To firmly establish the role of vitamin D regarding CVD risk factors we will in the present study include 600 subjects with vitamin D deficiency (serum 25-hydroxyvitamin D (25(OH)D) < 30 nmol/L) and randomize to high dose vitamin D (3000 IU per day) versus placebo for four months. The subjects will be recruited based on 25(OH)D measurements in the forthcoming 7th survey in the Tromsø study where more than 20 000 subjects are expected to attend. If our hypotheses are correct and the vitamin D supplement has a positive effect, this will be of great importance not only in countries with low sun exposure, but particularly for subjects in developing countries where vitamin D deficiency is highly prevalent.

Conditions

Vitamin D Deficiency

Keywords

vitamin D; blood pressure; serum lipids; glucose metabolism; muscle function; arterial stiffness; depression; psoriasis; sleep; bone density

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

cholecalciferol

vitamin D (as a 20 000 IU capsule) will be given once a week for 4 months

Group Type: ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type: DRUG

Vitamin D preparation

placebo

placebo capsules (identical looking to the vitamin D capsules) will be given once a week for 4 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo

Interventions

Cholecalciferol

Vitamin D preparation

Intervention Type: DRUG

Placebo

placebo

Intervention Type: DRUG

Other Intervention Names

Dekristol

Eligibility Criteria

Inclusion Criteria

• participated in The 7th survey in The Tromsø study
• vitamin D deficiency

Exclusion Criteria

• primary hyperparathyroidism
• granulomatous disease
• reduced kidney function
• systolic blood pressure > 174 mmHg
• diastolic blood pressure > 104 mmHg
• diabetes
• renal stones last 5 years
• use of solarium on regular basis
• planned holidays in tropical areas
• clinical depression
• clinical signs of vitamin D deficiency (muscle weakness)
• use of vitamin D supplements
• serious illness

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Tromso

OTHER

Sponsor Role: lead

Responsible Party

Rolf Jorde

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

rolf Jorde, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Tromso

Locations

University Hospital of North Norway

Tromsø, , Norway

Countries

Norway

References

Jorde R, Kubiak J, Svartberg J, Fuskevag OM, Figenschau Y, Martinaityte I, Grimnes G. Vitamin D supplementation has no effect on cognitive performance after four months in mid-aged and older subjects. J Neurol Sci. 2019 Jan 15;396:165-171. doi: 10.1016/j.jns.2018.11.020. Epub 2018 Nov 17.

Reference Type: DERIVED

PMID: 30472553 (View on PubMed)

Other Identifiers

2013-003514-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TromsøEndo-2013-1

Identifier Type: -

Identifier Source: org_study_id