The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors
- Registration Number
- NCT02750293
- Lead Sponsor
- University of Tromso
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 411
- participated in The 7th survey in The Tromsø study
- vitamin D deficiency
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo placebo capsules (identical looking to the vitamin D capsules) will be given once a week for 4 months cholecalciferol Cholecalciferol vitamin D (as a 20 000 IU capsule) will be given once a week for 4 months
- Primary Outcome Measures
Name Time Method Change from baseline in systolic and diastolic blood pressure 4 months
- Secondary Outcome Measures
Name Time Method Change from baseline in score on Becks Depression Inventory 4 months Change from baseline in cognitive function evaluated with The Twelve Word Memory Test 4 months Change from baseline in cognitive function evaluated with The Digit Symbol Coding Test 4 months Change from baseline in cognitive function evaluated with The Tapping Test 4 months Change from baseline in arterial stiffness and endothelial function evaluated with pulse wave velocity 4 months Change from baseline in arterial stiffness and endothelial function evaluated with augmentation index (AIX) 4 months Change from baseline in arterial stiffness and endothelial function evaluated with the subendocardial viability ratio (SEVR) 4 months Change from baseline in hand-grip, quadriceps and biceps muscle strength measured by hand held dynamometry . 4 months Change from baseline in number of subjects with nasal staphylococcus aureus colonization 4 months Change from baseline in bone mass density measured with dual energy x-ray absorptiometry (DEXA) at the lumbar spine and hip 4 months Change from baseline in the bone turnover marker serum type 1 procollagen (P1NP) 4 months Change from baseline in the bone turnover marker serum collagen type 1 cross-linked C-telopeptide (CTX-1) 4 months Change from baseline in serum marker of interferon-γ mediated macrophage activation 4 months Change from baseline in serum vitamin B6 status. 4 months Change from baseline in the glycosylation marker HbA1c 4 months Change from baseline in the glycosylation marker the receptor for advanced glycosylation end products (s-RAGE) 4 months Change from baseline in the glycosylation marker carboxy-methyllysine 4 months Change from baseline in psoriasis Activity in subjects with psoriasis evaluated with the Self-Administered Psoriasis Area Severity Index (SAPASI) 4 months Change from baseline in number of subjects with nocturnal legg cramps 4 months Change from baseline in sleep pattern evaluated with the Tromsø Study 7th Survey sleep pattern questionnaire 4 months Change from baseline in the serum total cholesterol 4 months Change from baseline in the serum HDL-cholesterol 4 months Change from baseline in the serum LDL-cholesterol 4 months Change from baseline in psoriasis Activity in subjects with psoriasis, evaluated with the Dermatological Life Quality Index (DLQI) 4 months Change from baseline in psoriasis Activity in subjects with psoriasis, evaluated with the Psoriasis Area Severity Index (PASI) 4 months Change from baseline in transcriptomic profile (mRNA) in adipose tissue biopsies 4 months Change from baseline in the serum triglycerides 4 months Change from baseline in the serum Apolipoprotein A1 4 months Change from baseline in the serum Apolipoprotein B, 4 months Change from baseline in insulin resistance evaluated with the homeostasis model assessment (HOMA) index based on fasting serum glucose and serum insulin 4 months Change from baseline in proteomic profile with relative quantification in adipose tissue biopsies with the use of Liquid chromatography mass spectrometry Technology (LC-MS/MS) 4 months Change from baseline in metabolomic profile with relative quantification in adipose tissue biopsies with the use of Liquid chromatography mass spectrometry Technology (LC-MS/MS) 4 months
Trial Locations
- Locations (1)
University Hospital of North Norway
🇳🇴Tromsø, Norway