Hypovitaminosis DPhase 3NCT03272126
Importance of Dosing Regimen for the Effect of Vitamin D Supplementation
A Phase 3 study testing Vitamin D in people with Hypovitaminosis D, run by University of Tromso at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypovitaminosis D
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteNorway
- Study dates
- 1 Dec 2017to 1 May 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Vitamin D, Placebo
- Keywords
- vitamin D
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
vitamin D given as bolus versus daily dosing
PlaceboDrug
identical looking as vitamin D
| Study group | Role | What they receive |
|---|---|---|
| vitamin D bolus | Experimental | vitamin D 160 000 IU given as bolus Receives: Drug: Vitamin D |
| vitamin D daily | Experimental | vitamin D 4000 IU daily for 28 days Receives: Drug: Vitamin D |
| placebo | Placebo comparator | identical looking as vitamin d Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepcidin change
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum hepcidin
Measured: 4 weeks
Secondary outcomes (6)
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
Measured: 4 weeks
Difference in micro RNA Expression after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Measured: 4 weeks
Difference in serum cathelicidin after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Measured: 4 weeks
Difference in RNA Expression after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Measured: 4 weeks
Difference in telomerase Activity after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Measured: 4 weeks
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start1 Dec 2017
- Primary completion1 Apr 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypovitaminosis DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- rolf jorde, MD PhD, Principal investigator, UiT, Tromsø
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272126
- Sponsor's protocol ID
- TromsøEndo-2017-1
- Status last verified
- Sep 2017
- First submitted
- 15 Jun 2017
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Dosing Regimen for the Effect of Vitamin D Supplementation
- ClinicalTrials.gov ID
- NCT03272126
- Acronym / sponsor ID
- TromsøEndo-2017-1
- Conditions
- Hypovitaminosis D
- Keywords
- vitamin D
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vitamin D bolus | Experimental | Drug: Vitamin Dvitamin D 160 000 IU given as bolus |
| vitamin D daily | Experimental | Drug: Vitamin Dvitamin D 4000 IU daily for 28 days |
| placebo | Placebo comparator | Drug: Placeboidentical looking as vitamin d |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- subjects allergic to peanuts
- subjects with primary hyperparathyroidism
- granulomatous diseases (sarcoidosis, tuberculosis, Wegner's granulomatosis)
- diabetes
- renal stones the last five years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin Dvitamin D given as bolus versus daily dosing | Drug | vitamin D bolus, vitamin D daily |
| Placeboidentical looking as vitamin D | Drug | placebo |
Primary outcome
Hepcidin change
Time frame: 4 weeks
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum hepcidin
6 secondary outcomes
Difference in serum PTH after 1 month
Time frame: 4 weeks
Difference in micro RNA Expression after 1 month
Time frame: 4 weeks
Difference in serum cathelicidin after 1 month
Time frame: 4 weeks
Difference in RNA Expression after 1 month
Time frame: 4 weeks
Difference in telomerase Activity after 1 month
Time frame: 4 weeks
Difference in ratio between 1,24(OH)2D and 24,24(OH)2D after 1 month
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
rolf jorde, MD PhD principal investigator
UiT, Tromsø
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D in people with Hypovitaminosis D, run by University of Tromso at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepcidin change (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.