Importance of Dosing Regimen for the Effect of Vitamin D Supplementation

Hypovitaminosis D Clinical Trial

Official title:

Importance of Dosing Regimen for the Effect of Vitamin D Supplementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272126
• Other study ID #: TromsøEndo-2017-1
• Status: Completed
• Phase: Phase 3
• Start date: December 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: September 2017
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Avitaminosis
• Hypovitaminosis D
• Rickets
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D
vitamin D given as bolus versus daily dosing
• Placebo
identical looking as vitamin D

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø

Sponsors (1)

Lead Sponsor	Collaborator
University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepcidin change	Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum hepcidin	4 weeks
Secondary	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	4 weeks
Secondary	Difference in micro RNA Expression after 1 month	Difference between vitamin D given as a bolus 160 000IU vs 4000 IU	4 weeks
Secondary	Difference in serum cathelicidin after 1 month	Difference between vitamin D given as a bolus 160 000IU vs 4000 IU	4 weeks
Secondary	Difference in RNA Expression after 1 month	Difference between vitamin D given as a bolus 160 000IU vs 4000 IU	4 weeks
Secondary	Difference in telomerase Activity after 1 month	Difference between vitamin D given as a bolus 160 000IU vs 4000 IU	4 weeks
Secondary	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	4 weeks