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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Vitamin D3, 10 000 IU daily. Treatment to patients with Serum-vitamin D levels below 25 nmol/L |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol high dose at Vitamin D deficiency | Drug | 10 000 IU daily i.e. 15 drops orally once daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum-vitamin D | Levels of serum vitamin D3 | Baseline |
| Level of Vitamin D at End of the Treatment Period of 12 Weeks | Serum Vitamin D, 25-(OH)D | End of treatment period 12 weeks after baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margareta Norberg, M.D. Ph.D | Dept of Epidemiology and Global Health, Umeå University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ålidhems hälsocentral, Umeå | Umeå | Se-90736 | Sweden |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Vitamin D3, 10 000 IU daily. Treatment to patients with Serum-vitamin D levels below 25 nmol/L Cholecalciferol: 10 000 IU daily i.e. 15 drops orally once daily for 12 weeks |
| FG001 | Group 2a | 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 Cholecalciferol: 2000 IU daily i.e. 3 drops orally once a day for 12 weeks, |
| FG002 | Group 2b | 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 Cholecalciferol: 2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks, |
| FG003 | Group 3 | 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 Cholecalciferol: 2000 IU daily i.e. 3 drops orally once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only participants who completed the study protocol, i.e.analyses per protocol
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Vitamin D3, 10 000 IU daily. Treatment to patients with Serum-vitamin D levels below 25 nmol/L Cholecalciferol: 10 000 IU daily i.e. 15 drops orally once daily for 12 weeks |
| BG001 | Group 2a |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum-vitamin D | Levels of serum vitamin D3 | Participants who completed the study protocol | Posted | Mean | Standard Deviation | 25(OH)D, nmol/L | Baseline |
|
The treatment period of 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Vitamin D3, 10 000 IU daily. Treatment to patients with Serum-vitamin D levels below 25 nmol/L Cholecalciferol: 10 000 IU daily i.e. 15 drops orally once daily for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suspected serious adverse event | Psychiatric disorders | Systematic Assessment | Mental agitation. The subject doubled the study medication concomitantly with changes of anti-depressant medication. Unclear whether symptoms wer due to a rapid increase to high serum 25(OH)D levels or the anti-depressive medication. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Events | General disorders | Systematic Assessment | The AEs were miscellaneous and mild without any clear pattern, while four were due to other causes or conditions that were known before the study. Examples: obstipation, headache, pain in the wrists |
This open partly RCT was conducted during September 2011-May 2012 at the Umeå University Hospital Clinical Research Centre, monitored by the Clinical Trial Unit, Region Västerbotten, Sweden. The study treatment was vitamin D supplementation (25(OH)D) during 12 weeks.
The trial was reported to the Swedish Medical Products Agency in August 2013 and to the European Medicines Agency in November 2021. No reports have been accepted to publication in Scientific journals
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Margareta Norberg | Umea University, Umeå, Sweden | +46702618614 | margareta.norberg@umu.se |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Cholecalciferol median dose at Vitamin D insufficiency | Drug | 2000 IU daily i.e. 3 drops orally once a day for 12 weeks, |
|
|
| Cholecalciferol low dose at Vitamin D deficiency | Drug | 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 level | Drug | 2000 IU daily i.e. 3 drops orally once daily for 12 weeks |
|
|
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
Cholecalciferol: 2000 IU daily i.e. 3 drops orally once a day for 12 weeks,
| BG002 | Group 2b | 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 Cholecalciferol: 2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks, |
| BG003 | Group 3 | 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 Cholecalciferol: 2000 IU daily i.e. 3 drops orally once daily for 12 weeks |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Group 2b | 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 Cholecalciferol: 2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks, |
| OG003 | Group 3 | 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 Cholecalciferol: 2000 IU daily i.e. 3 drops orally once daily for 12 weeks |
|
|
|
| Primary | Level of Vitamin D at End of the Treatment Period of 12 Weeks | Serum Vitamin D, 25-(OH)D | Posted | Mean | Standard Deviation | 25(OH)D, nmol/L | End of treatment period 12 weeks after baseline |
|
|
|
|
| 0 |
| 23 |
| 1 |
| 23 |
| 8 |
| 23 |
| EG001 | Group 2a | 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 Cholecalciferol: 2000 IU daily i.e. 3 drops orally once a day for 12 weeks, | 0 | 56 | 0 | 56 | 19 | 56 |
| EG002 | Group 2b | 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 Cholecalciferol: 2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks, | 0 | 50 | 0 | 50 | 12 | 50 |
| EG003 | Group 3 | 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 Cholecalciferol: 2000 IU daily i.e. 3 drops orally once daily for 12 weeks | 0 | 31 | 0 | 31 | 5 | 31 |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D004364 | Pharmaceutical Preparations |