Trial Outcomes & Findings for Vitamin Deficiency in Immigrants, a Treatment Study (NCT NCT01419119)
NCT ID: NCT01419119
Last Updated: 2024-07-18
Results Overview
Levels of serum vitamin D3
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
160 participants
Primary outcome timeframe
Baseline
Results posted on
2024-07-18
Participant Flow
Participant milestones
| Measure |
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
|
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,
|
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,
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
56
|
50
|
31
|
|
Overall Study
COMPLETED
|
16
|
54
|
49
|
28
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin Deficiency in Immigrants, a Treatment Study
Baseline characteristics by cohort
| Measure |
Group 1
n=16 Participants
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
|
Group 2a
n=54 Participants
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,
|
Group 2b
n=49 Participants
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,
|
Group 3
n=28 Participants
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
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
41.3 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
40.9 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
41.7 years
STANDARD_DEVIATION 10.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Region of Enrollment
Sweden
|
16 participants
n=5 Participants
|
54 participants
n=7 Participants
|
49 participants
n=5 Participants
|
28 participants
n=4 Participants
|
147 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Participants who completed the study protocol
Levels of serum vitamin D3
Outcome measures
| Measure |
Group 1
n=16 Participants
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
|
Group 2a
n=54 Participants
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,
|
Group 2b
n=49 Participants
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,
|
Group 3
n=28 Participants
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
|
|---|---|---|---|---|
|
Serum-vitamin D
|
19.7 25(OH)D, nmol/L
Standard Deviation 4.0
|
34.4 25(OH)D, nmol/L
Standard Deviation 6.5
|
38.7 25(OH)D, nmol/L
Standard Deviation 6.5
|
58.7 25(OH)D, nmol/L
Standard Deviation 6.3
|
PRIMARY outcome
Timeframe: End of treatment period 12 weeks after baselineSerum Vitamin D, 25-(OH)D
Outcome measures
| Measure |
Group 1
n=16 Participants
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
|
Group 2a
n=54 Participants
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,
|
Group 2b
n=49 Participants
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,
|
Group 3
n=28 Participants
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
|
|---|---|---|---|---|
|
Level of Vitamin D at End of the Treatment Period of 12 Weeks
|
140.8 25(OH)D, nmol/L
Standard Deviation 31.9
|
72.5 25(OH)D, nmol/L
Standard Deviation 14.6
|
52.3 25(OH)D, nmol/L
Standard Deviation 9.9
|
81.0 25(OH)D, nmol/L
Standard Deviation 14.8
|
Adverse Events
Group 1
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2a
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Group 2b
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=23 participants at risk
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
|
Group 2a
n=56 participants at risk
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,
|
Group 2b
n=50 participants at risk
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,
|
Group 3
n=31 participants at risk
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
|
|---|---|---|---|---|
|
Psychiatric disorders
Suspected serious adverse event
|
4.3%
1/23 • Number of events 1 • The treatment period of 12 weeks
|
0.00%
0/56 • The treatment period of 12 weeks
|
0.00%
0/50 • The treatment period of 12 weeks
|
0.00%
0/31 • The treatment period of 12 weeks
|
Other adverse events
| Measure |
Group 1
n=23 participants at risk
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
|
Group 2a
n=56 participants at risk
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,
|
Group 2b
n=50 participants at risk
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,
|
Group 3
n=31 participants at risk
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
|
|---|---|---|---|---|
|
General disorders
Adverse Events
|
34.8%
8/23 • Number of events 8 • The treatment period of 12 weeks
|
33.9%
19/56 • Number of events 19 • The treatment period of 12 weeks
|
24.0%
12/50 • Number of events 12 • The treatment period of 12 weeks
|
16.1%
5/31 • Number of events 5 • The treatment period of 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place