Status:
COMPLETED
Importance of Dosing Regimen for the Effect of Vitamin D Supplementation
Lead Sponsor:
University of Tromso
Conditions:
Hypovitaminosis D
Eligibility:
All Genders
20-70 years
Phase:
PHASE3
Brief Summary
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), type 2 diabetes, cancer, infectious a...
Eligibility Criteria
Inclusion
- Males and females 20 - 70 years
- 20 kg/m2 \> BMI \< 35 kg/m2
- systolic BP \< 175 mmHg, diastolic BP \< 105 mmHg
- Serum 25(OH)D level \< 50 nmol/L. Serum 25(OH)D \< 50 nmol/L is considered as vitamin D deficiency, and accordingly, effects of vitamin D supplementation will be easier to detect than if the included subjects were vitamin D sufficient.
- Hgb, SR, CRP, creatinine \< 130 umol/L in males, \< 120 umol/L in females, calcium, FT4 and TSH within the normal reference range; ASAT \< 90 mU/L ALAT \< 140 U/L, HbA1c \< 6.6 %
- The subjects must agree not to take any vitamin D supplementation, including cod liver oil or "mølje", use solarium or go on sunny vacation during the intervention period.
Exclusion
- subjects allergic to peanuts
- subjects with primary hyperparathyroidism
- granulomatous diseases (sarcoidosis, tuberculosis, Wegner's granulomatosis)
- diabetes
- renal stones the last five years
- subjects seriously ill (or with chronic disease) and unfit for participation in the study (as judged by one of the study doctors)
- subjects using vitamin D supplements exceeding 800 IU per day or active vitamin D drugs (Rocaltrol or Etalpha)
- pregnancy
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03272126
Start Date
December 1 2017
End Date
May 1 2018
Last Update
May 24 2018
Active Locations (1)
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1
University Hospital of North Norway
Tromsø, Norway, 9038