Importance of Dosing Regimen for the Effect of Vitamin D Supplementation

NCT03272126 | Completed Phase 3

• 1 other identifier: TromsøEndo-2017-1
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypovitaminosis D

Keywords

vitamin D

Outcome Measures

Primary Outcomes (1)

• Hepcidin change

  Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum hepcidin

  4 weeks

Secondary Outcomes (6)

• Difference in serum PTH after 1 month

  4 weeks

• Difference in micro RNA Expression after 1 month

  4 weeks

• Difference in serum cathelicidin after 1 month

  4 weeks

• Difference in RNA Expression after 1 month

  4 weeks

• Difference in telomerase Activity after 1 month

  4 weeks

Study Arms (3)

vitamin D bolus

EXPERIMENTAL

vitamin D 160 000 IU given as bolus

Drug: Vitamin D

vitamin D daily

EXPERIMENTAL

vitamin D 4000 IU daily for 28 days

Drug: Vitamin D

placebo

PLACEBO COMPARATOR

identical looking as vitamin d

Drug: Placebo

Interventions

Vitamin D DRUG

vitamin D given as bolus versus daily dosing

vitamin D bolus; vitamin D daily

Placebo DRUG

identical looking as vitamin D

placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tromso: lead

Study Sites (1)

University Hospital of North Norway

Tromsø, 9038, Norway

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• rolf jorde, MD PhD

  UiT, Tromsø

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: September 5, 2017
• Study Start: December 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 24, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)