Vitamin D DeficiencyPhase 4VIDI2NCT01419119
Vitamin Deficiency in Immigrants, a Treatment Study
A Phase 4 study testing Cholecalciferol high dose at Vitamin D deficiency, Cholecalciferol median dose at Vitamin D insufficiency and Cholecalciferol low dose at Vitamin D deficiency in people with Vitamin D Deficiency, run by Umeå University at 1 site in Sweden.
Trial summary
The purpose of this study is to determine the efficacy of different doses of vitamin D in persons, immigrated to Sweden from Middle East or Africa, with decreased S vitamin D. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Cholecalciferol high dose at Vitamin D deficiency, Cholecalciferol median dose at Vitamin D insufficiency and Cholecalciferol low dose at Vitamin D deficiency
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2011to Oct 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serum- vitamin D below 75 nmol/L
- Men and female
- 25-65 years of age
- Born in Middle East or Africa, living in Umeå district
Who cannot join
- Hypersensitive to Cholecalciferol, cocos oil, palm kernel or rubber
- Serum D3 equal to or above75 nmol/L
- Hypercalcemia
- Renal insufficiency
- History of Kidney Calculi
- Nephrocalcinosis
Show all 20Show fewer
- History of sarcoidosis and other Granulomatous Diseases
- Known malignancy
- Ongoing treatment with phenytoin, barbiturates, rifampicin, isoniazid
- Ongoing treatment with cardiac glycosides
- Ongoing treatment with thiazides
- Ongoing treatment with Etalpha, Rocaltrol, ergocalciferol, Dygratal
- Ongoing treatment with drugs involving fat absorption; Orlistat Colestyramin
- Oral treatment with glucocorticoids
- Ongoing treatment with Aluminum Compounds drugs
- Ongoing treatment with Omega -3, vitamin D and/or calcium
- Immobilisation
- Other medial reason not to participate according to the investigator
- Pregnancy (women with S-D3 below 25 nmol/)
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study, Four Parallel Arms, Included Two Arms Open Randomisation to Different Doses of Vitamin D, for Assessment of Efficacy of Treatment With Vitamin D at Vitamin D Deficiency, Vitamin D Insufficiency and Suboptimal Levels of Vitamin D
The purpose of this study is to determine the efficacy of different doses of vitamin D in persons, immigrated to Sweden from Middle East or Africa, with decreased S vitamin D.
Read the detailed description
The participants in the study have taken part in a previous screening study. They are now asked to participate in this treatment study. At a screening visit blood samples for vitamin D3 and PTH are collected. Data regarding previous fractures, life style, exposure for sun, clothes, diet, smoking and physical activities are collected. The Vitamin D value predict the treatment dose.
- Conditions
- Vitamin D Deficiency
- Being tested
- Cholecalciferol high dose at Vitamin D deficiency, Cholecalciferol median dose at Vitamin D insufficiency, Cholecalciferol low dose at Vitamin D deficiency, Cholecalciferol median dose at sufficient Vitamin D level
- Keywords
- vitamin D insufficiency, Cholecalciferol, D3, Parathyroid Hormone, 25-hydroxyvitamin D3, RDA, recommended daily intake (nutrition policy), Vitamin D, Hypovitaminosis-D, Pharmacologic treatment
- 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.
Cholecalciferol high dose at Vitamin D deficiencyDrug
Also called Vigantol Oil 20 000 IU/ml, drops for oral use, solution
10 000 IU daily i.e. 15 drops orally once daily for 12 weeks
Cholecalciferol median dose at Vitamin D insufficiencyDrug
Also called Vigantol Oil 20 000 IU/ml, drops for oral use, solution
2000 IU daily i.e. 3 drops orally once a day for 12 weeks,
Cholecalciferol low dose at Vitamin D deficiencyDrug
Also called Vigantol Oil 20 000 IU/ml, drops for oral use, solution
2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks,
Cholecalciferol median dose at sufficient Vitamin D levelDrug
Also called Vigantol Oil 20 000 IU/ml, drops for oral use, solution
2000 IU daily i.e. 3 drops orally once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Vitamin D3, 10 000 IU daily. Treatment to patients with Serum-vitamin D levels below 25 nmol/L Receives: Drug: Cholecalciferol high dose at Vitamin D deficiency |
| Group 2a | Experimental | Vitamin D3 2000 IU daily, one of two arms that patients with Serum-vitamin D levels between 25 nmol/L and 49 nmol/l will be randomised to Receives: Drug: Cholecalciferol median dose at Vitamin D insufficiency |
| Group 2b | Experimental | Vitamin D3 2000 IU weekly, one of two arms that patients with Serum-vitamin D levels between 25 nmol/L and 49 mol/l will be randomised to Receives: Drug: Cholecalciferol low dose at Vitamin D deficiency |
| Group 3 | Experimental | Vitamin D3, 2000 IU daily i.e. 3 drops orally once daily for 12 weeks, treatment to patients with Serum-vitamin D levels between 50 and 74 nmol/L Receives: Drug: Cholecalciferol median dose at sufficient Vitamin D level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum-vitamin D
Levels of serum vitamin D3
Measured: Baseline
Level of Vitamin D at End of the Treatment Period of 12 Weeks
Serum Vitamin D, 25-(OH)D
Measured: End of treatment period 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margareta Norberg, Umeå University
- Investigators
- Margareta Norberg, M.D. Ph.D, Principal investigator, Dept of Epidemiology and Global Health, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419119
- Sponsor's protocol ID
- VIDI 2
- Acronym
- VIDI2
- Status last verified
- Feb 2024
- First submitted
- 16 Aug 2011
- Last updated
- 18 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study, Four Parallel Arms, Included Two Arms Open Randomisation to Different Doses of Vitamin D, for Assessment of Efficacy of Treatment With Vitamin D at Vitamin D Deficiency, Vitamin D Insufficiency and Suboptimal Levels of Vitamin D
- ClinicalTrials.gov ID
- NCT01419119
- Acronym / sponsor ID
- VIDI2 / VIDI 2
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D insufficiency, Cholecalciferol, D3, Parathyroid Hormone, 25-hydroxyvitamin D3, RDA, recommended daily intake (nutrition policy), Vitamin D, Hypovitaminosis-D
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 17 Aug 2011 (estimated)
- Results
- Posted 18 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy of different doses of vitamin D in persons, immigrated to Sweden from Middle East or Africa, with decreased S vitamin D.
Detailed description
The participants in the study have taken part in a previous screening study. They are now asked to participate in this treatment study. At a screening visit blood samples for vitamin D3 and PTH are collected. Data regarding previous fractures, life style, exposure for sun, clothes, diet, smoking and physical activities are collected. The Vitamin D value predict the treatment dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Cholecalciferol high dose at Vitamin D deficiencyVitamin D3, 10 000 IU daily. Treatment to patients with Serum-vitamin D levels below 25 nmol/L |
| Group 2a | Experimental | Drug: Cholecalciferol median dose at Vitamin D insufficiencyVitamin D3 2000 IU daily, one of two arms that patients with Serum-vitamin D levels between 25 nmol/L and 49 nmol/l will be randomised to |
| Group 2b | Experimental | Drug: Cholecalciferol low dose at Vitamin D deficiencyVitamin D3 2000 IU weekly, one of two arms that patients with Serum-vitamin D levels between 25 nmol/L and 49 mol/l will be randomised to |
| Group 3 | Experimental | Drug: Cholecalciferol median dose at sufficient Vitamin D levelVitamin D3, 2000 IU daily i.e. 3 drops orally once daily for 12 weeks, treatment to patients with Serum-vitamin D levels between 50 and 74 nmol/L |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Serum- vitamin D below 75 nmol/L
- Men and female
- 25-65 years of age
- Born in Middle East or Africa, living in Umeå district
Key exclusion criteria (20 listed)
- Hypersensitive to Cholecalciferol, cocos oil, palm kernel or rubber
- Serum D3 equal to or above75 nmol/L
- Hypercalcemia
- Renal insufficiency
- History of Kidney Calculi
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 |
|---|---|---|
| Cholecalciferol high dose at Vitamin D deficiencyAlso: Vigantol Oil 20 000 IU/ml, drops for oral use, solution10 000 IU daily i.e. 15 drops orally once daily for 12 weeks | Drug | Group 1 |
| Cholecalciferol median dose at Vitamin D insufficiencyAlso: Vigantol Oil 20 000 IU/ml, drops for oral use, solution2000 IU daily i.e. 3 drops orally once a day for 12 weeks, | Drug | Group 2a |
| Cholecalciferol low dose at Vitamin D deficiencyAlso: Vigantol Oil 20 000 IU/ml, drops for oral use, solution2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks, | Drug | Group 2b |
| Cholecalciferol median dose at sufficient Vitamin D levelAlso: Vigantol Oil 20 000 IU/ml, drops for oral use, solution2000 IU daily i.e. 3 drops orally once daily for 12 weeks | Drug | Group 3 |
Primary outcome
Serum-vitamin D
Time frame: Baseline
Levels of serum vitamin D3
Level of Vitamin D at End of the Treatment Period of 12 Weeks
Time frame: End of treatment period 12 weeks after baseline
Serum Vitamin D, 25-(OH)D
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Vitamin D Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
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.
Margareta Norberg, M.D. Ph.D principal investigator
Dept of Epidemiology and Global Health, Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cholecalciferol high dose at Vitamin D deficiency, Cholecalciferol median dose at Vitamin D insufficiency and Cholecalciferol low dose at Vitamin D deficiency in people with Vitamin D Deficiency, run by Umeå University at 1 site in Sweden.
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 4 inclusion and 20 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 18 Jul 2024. 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 Sweden. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum-vitamin D (time frame: Baseline). The study lists 2 primary outcomes in all. 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 18 Jul 2024.