Vitamin D Deficiency
Conditions
Keywords
vitamin D insufficiency, Cholecalciferol, D3, Parathyroid Hormone, 25-hydroxyvitamin D3, RDA, recommended daily intake (nutrition policy), Vitamin D, Hypovitaminosis-D, Pharmacologic treatment
Brief 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.
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.
Interventions
DRUGCholecalciferol high dose at Vitamin D deficiency
10 000 IU daily i.e. 15 drops orally once daily for 12 weeks
DRUGCholecalciferol median dose at Vitamin D insufficiency
2000 IU daily i.e. 3 drops orally once a day for 12 weeks,
DRUGCholecalciferol low dose at Vitamin D deficiency
2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks,
DRUGCholecalciferol median dose at sufficient Vitamin D level
2000 IU daily i.e. 3 drops orally once daily for 12 weeks
Sponsors
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum-vitamin D | Baseline | Levels of serum vitamin D3 |
| Level of Vitamin D at End of the Treatment Period of 12 Weeks | End of treatment period 12 weeks after baseline | Serum Vitamin D, 25-(OH)D |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| 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, | 54 |
| 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, | 49 |
| 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 | 28 |
| Total | 147 |
Baseline characteristics
| Characteristic | Group 1 | Group 2a | Group 2b | Group 3 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 42.4 years STANDARD_DEVIATION 11.2 | 41.3 years STANDARD_DEVIATION 11.5 | 40.9 years STANDARD_DEVIATION 9.8 | 43.2 years STANDARD_DEVIATION 11.2 | 41.7 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment Sweden | 16 participants | 54 participants | 49 participants | 28 participants | 147 participants |
| Sex: Female, Male Female | 5 Participants | 26 Participants | 23 Participants | 14 Participants | 68 Participants |
| Sex: Female, Male Male | 11 Participants | 28 Participants | 26 Participants | 14 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 56 | 0 / 50 | 0 / 31 |
| other Total, other adverse events | 8 / 23 | 19 / 56 | 12 / 50 | 5 / 31 |
| serious Total, serious adverse events | 1 / 23 | 0 / 56 | 0 / 50 | 0 / 31 |
Outcome results
Primary
Level of Vitamin D at End of the Treatment Period of 12 Weeks
Serum Vitamin D, 25-(OH)D
Time frame: End of treatment period 12 weeks after baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Level of Vitamin D at End of the Treatment Period of 12 Weeks | 140.8 25(OH)D, nmol/L | Standard Deviation 31.9 |
| Group 2a | Level of Vitamin D at End of the Treatment Period of 12 Weeks | 72.5 25(OH)D, nmol/L | Standard Deviation 14.6 |
| Group 2b | Level of Vitamin D at End of the Treatment Period of 12 Weeks | 52.3 25(OH)D, nmol/L | Standard Deviation 9.9 |
| Group 3 | Level of Vitamin D at End of the Treatment Period of 12 Weeks | 81.0 25(OH)D, nmol/L | Standard Deviation 14.8 |
p-value: 0.001t-test, 2 sided
Primary
Serum-vitamin D
Levels of serum vitamin D3
Time frame: Baseline
Population: Participants who completed the study protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Serum-vitamin D | 19.7 25(OH)D, nmol/L | Standard Deviation 4 |
| Group 2a | Serum-vitamin D | 34.4 25(OH)D, nmol/L | Standard Deviation 6.5 |
| Group 2b | Serum-vitamin D | 38.7 25(OH)D, nmol/L | Standard Deviation 6.5 |
| Group 3 | Serum-vitamin D | 58.7 25(OH)D, nmol/L | Standard Deviation 6.3 |
p-value: 0.001t-test, 2 sided