Importance of Dosing Regimen for the Effect of Vitamin D Supplementation
Primary Purpose
Hypovitaminosis D
Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hypovitaminosis D focused on measuring vitamin D
Eligibility Criteria
Inclusion Criteria:- 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 Criteria:
- 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
Sites / Locations
- University Hospital of North Norway
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
vitamin D bolus
vitamin D daily
placebo
Arm Description
vitamin D 160 000 IU given as bolus
vitamin D 4000 IU daily for 28 days
identical looking as vitamin d
Outcomes
Primary Outcome Measures
Hepcidin change
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum hepcidin
Secondary Outcome Measures
Difference in serum PTH after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum PTH, cathelicidin, RNA expression and micro RNA in peripheral blood, telomerase activity and the ratio between 1,25(OH)2D and 24,25(OH)2D, after 1 month
Difference in micro RNA Expression after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Difference in serum cathelicidin after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Difference in RNA Expression after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Difference in telomerase Activity after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Difference in ratio between 1,24(OH)2D and 24,24(OH)2D after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03272126
Brief Title
Importance of Dosing Regimen for the Effect of Vitamin D Supplementation
Official Title
Importance of Dosing Regimen for the Effect of Vitamin D Supplementation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tromso
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 and immunological diseases, as well as risk factors for these diseases. However, intervention studies with vitamin D have been inconclusive regarding diseases and risk factors. This could be due to inclusion of subjects already vitamin D sufficient, and short and underpowered studies. In addition, there are indications that the dosing regimens may be important, so that daily doses with vitamin D are more efficient than intermittent doses, which so far have been generally used. This could be related to the concentration of circulating and thereby intracellular vitamin D concentrations, which probably is dependent on daily vitamin D doses. This will be tested in the present study where 60 subjects will be randomized to vitamin D 160 000 once, vitamin D 4000 IU/day, or placebo for four weeks. The primary endpoints will be effects on serum hepcidin and plasma cathelicidin after 4 weeks, with effects on serum PTH, RNA expression and microRNA in peripheral blood, telomerase activity in peripheral blood mononuclear cells and the ration between serum 1,25(OH)2D and 24,25(OH)2D as secondary endpoints.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovitaminosis D
Keywords
vitamin D
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitamin D bolus
Arm Type
Experimental
Arm Description
vitamin D 160 000 IU given as bolus
Arm Title
vitamin D daily
Arm Type
Experimental
Arm Description
vitamin D 4000 IU daily for 28 days
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
identical looking as vitamin d
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
vitamin D given as bolus versus daily dosing
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
identical looking as vitamin D
Primary Outcome Measure Information:
Title
Hepcidin change
Description
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum hepcidin
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Difference in serum PTH after 1 month
Description
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum PTH, cathelicidin, RNA expression and micro RNA in peripheral blood, telomerase activity and the ratio between 1,25(OH)2D and 24,25(OH)2D, after 1 month
Time Frame
4 weeks
Title
Difference in micro RNA Expression after 1 month
Description
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Time Frame
4 weeks
Title
Difference in serum cathelicidin after 1 month
Description
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Time Frame
4 weeks
Title
Difference in RNA Expression after 1 month
Description
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Time Frame
4 weeks
Title
Difference in telomerase Activity after 1 month
Description
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Time Frame
4 weeks
Title
Difference in ratio between 1,24(OH)2D and 24,24(OH)2D after 1 month
Description
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:- 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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
rolf jorde, MD PhD
Organizational Affiliation
UiT, Tromsø
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of North Norway
City
Tromsø
ZIP/Postal Code
9038
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
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Importance of Dosing Regimen for the Effect of Vitamin D Supplementation
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