Trial Outcomes & Findings for Vitamin D in Treating Patients With Prostate Cancer (NCT NCT00524680)
NCT ID: NCT00524680
Last Updated: 2015-11-02
Results Overview
Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
148 participants
Primary outcome timeframe
Baseline, at 1, 3, 6 months
Results posted on
2015-11-02
Participant Flow
Total 148 patients were treated but only 128 patients were eligible for study outcome analysis.
Participant milestones
| Measure |
Arm I: Vitamin D 4000 IU Daily
Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
cholecalciferol: Given orally
|
Arm II: Vitamin D 6000 IU Daily
Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm III: Vitamin D 8000 IU Daily
Patients receive 8,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm IV: Vitamin D 10,000 IU Daily
Patients receive 10,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
37
|
35
|
36
|
40
|
|
Overall Study
COMPLETED
|
34
|
34
|
33
|
34
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
3
|
6
|
Reasons for withdrawal
| Measure |
Arm I: Vitamin D 4000 IU Daily
Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
cholecalciferol: Given orally
|
Arm II: Vitamin D 6000 IU Daily
Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm III: Vitamin D 8000 IU Daily
Patients receive 8,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm IV: Vitamin D 10,000 IU Daily
Patients receive 10,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
|---|---|---|---|---|
|
Overall Study
progression
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
1
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
Baseline Characteristics
Vitamin D in Treating Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm I: Vitamin D 4000 IU Daily
n=37 Participants
Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
cholecalciferol: Given orally
|
Arm II: Vitamin D 6000 IU Daily
n=35 Participants
Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm III: Vitamin D 8000 IU Daily
n=36 Participants
Patients receive 8,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm IV: Vitamin D 10,000 IU Daily
n=40 Participants
Patients receive 10,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
68.2 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
65.4 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
67.9 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
66.5 years
STANDARD_DEVIATION 8.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
148 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, at 1, 3, 6 monthsPopulation: All treated and eligible patients
Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.
Outcome measures
| Measure |
Arm I: Vitamin D 4000 IU Daily
n=33 Participants
Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
cholecalciferol: Given orally
|
Arm II: Vitamin D 6000 IU Daily
n=31 Participants
Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm III: Vitamin D 8000 IU Daily
n=32 Participants
Patients receive 8,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm IV: Vitamin D 10,000 IU Daily
n=32 Participants
Patients receive 10,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
|---|---|---|---|---|
|
Pattern of Response of Serum 25(OH) D3 Levels
3-month
|
23.45 ng/mL
Standard Deviation 11.99
|
38.31 ng/mL
Standard Deviation 22.24
|
35.76 ng/mL
Standard Deviation 26.28
|
45.67 ng/mL
Standard Deviation 21.5
|
|
Pattern of Response of Serum 25(OH) D3 Levels
1-month
|
11.34 ng/mL
Standard Deviation 13.03
|
24.84 ng/mL
Standard Deviation 16.18
|
18.87 ng/mL
Standard Deviation 22.25
|
26.91 ng/mL
Standard Deviation 16.1
|
|
Pattern of Response of Serum 25(OH) D3 Levels
6-month
|
27.16 ng/mL
Standard Deviation 15.69
|
43.4 ng/mL
Standard Deviation 29.28
|
41.7 ng/mL
Standard Deviation 27.07
|
57.59 ng/mL
Standard Deviation 27.91
|
SECONDARY outcome
Timeframe: Baseline, at 1, 3, 6 monthsPopulation: All treated and eligible patients
Change from Baseline in PTH Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.
Outcome measures
| Measure |
Arm I: Vitamin D 4000 IU Daily
n=33 Participants
Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
cholecalciferol: Given orally
|
Arm II: Vitamin D 6000 IU Daily
n=31 Participants
Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm III: Vitamin D 8000 IU Daily
n=32 Participants
Patients receive 8,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm IV: Vitamin D 10,000 IU Daily
n=32 Participants
Patients receive 10,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
|---|---|---|---|---|
|
Pattern of Response of Parathormone
6-month
|
-8.4 pg/mL
Standard Deviation 33.05
|
-24.05 pg/mL
Standard Deviation 26.77
|
-9.78 pg/mL
Standard Deviation 34.22
|
-16.51 pg/mL
Standard Deviation 45.94
|
|
Pattern of Response of Parathormone
1-month
|
-.73 pg/mL
Standard Deviation 18.82
|
-12.18 pg/mL
Standard Deviation 43.33
|
-1.28 pg/mL
Standard Deviation 31.84
|
-10.37 pg/mL
Standard Deviation 46.24
|
|
Pattern of Response of Parathormone
3-month
|
-11.3 pg/mL
Standard Deviation 37.99
|
.24 pg/mL
Standard Deviation 34.01
|
-8.03 pg/mL
Standard Deviation 32.77
|
-18.06 pg/mL
Standard Deviation 35.31
|
SECONDARY outcome
Timeframe: Baseline, at 1, 3 and 6 monthsPopulation: All treated and eligible patients
Number of treated patients that had serious adverse events.
Outcome measures
| Measure |
Arm I: Vitamin D 4000 IU Daily
n=37 Participants
Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
cholecalciferol: Given orally
|
Arm II: Vitamin D 6000 IU Daily
n=35 Participants
Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm III: Vitamin D 8000 IU Daily
n=36 Participants
Patients receive 8,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm IV: Vitamin D 10,000 IU Daily
n=40 Participants
Patients receive 10,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
|---|---|---|---|---|
|
Toxicity
|
2 participants
|
0 participants
|
1 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline, at 1, 3 ,6 monthsPopulation: All treated and eligible patients
Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls
Outcome measures
| Measure |
Arm I: Vitamin D 4000 IU Daily
n=37 Participants
Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
cholecalciferol: Given orally
|
Arm II: Vitamin D 6000 IU Daily
n=35 Participants
Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm III: Vitamin D 8000 IU Daily
n=36 Participants
Patients receive 8,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm IV: Vitamin D 10,000 IU Daily
n=40 Participants
Patients receive 10,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
|---|---|---|---|---|
|
Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls
|
2 participants
|
0 participants
|
2 participants
|
2 participants
|
Adverse Events
Arm I: Vitamin D 4000 IU Daily
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm II: Vitamin D 6000 IU Daily
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm III: Vitamin D 8000 IU Daily
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm IV: Vitamin D 10,000 IU Daily
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I: Vitamin D 4000 IU Daily
n=37 participants at risk
Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
cholecalciferol: Given orally
|
Arm II: Vitamin D 6000 IU Daily
n=35 participants at risk
Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm III: Vitamin D 8000 IU Daily
n=36 participants at risk
Patients receive 8,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm IV: Vitamin D 10,000 IU Daily
n=40 participants at risk
Patients receive 10,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/36
|
0.00%
0/40
|
|
Cardiac disorders
Arrhythmia
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/36
|
0.00%
0/40
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/36
|
0.00%
0/40
|
|
General disorders
Chest pain
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Pain
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/36
|
0.00%
0/40
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/36
|
0.00%
0/40
|
|
Investigations
Investigation
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.00%
0/37
|
0.00%
0/35
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/37
|
0.00%
0/35
|
2.8%
1/36 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
Surgical and medical procedures
Radical prostatectomy
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
Other adverse events
| Measure |
Arm I: Vitamin D 4000 IU Daily
n=37 participants at risk
Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
cholecalciferol: Given orally
|
Arm II: Vitamin D 6000 IU Daily
n=35 participants at risk
Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm III: Vitamin D 8000 IU Daily
n=36 participants at risk
Patients receive 8,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
Arm IV: Vitamin D 10,000 IU Daily
n=40 participants at risk
Patients receive 10,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Thirst
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/36
|
0.00%
0/40
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/37
|
0.00%
0/35
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Influenza
|
0.00%
0/37
|
0.00%
0/35
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/37
|
0.00%
0/35
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Pneumonia
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/36
|
0.00%
0/40
|
|
Investigations
Aspartate aminotransferase increased
|
2.7%
1/37 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
0.00%
0/36
|
2.5%
1/40 • Number of events 2
|
|
Investigations
Blood 1,25-dihydroxycholecalciferol increased
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Investigations
Blood albumin decreased
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 2
|
|
Investigations
Blood glucose increased
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Investigations
Haemoglobin increased
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/36
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/36
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/36
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/37
|
5.7%
2/35 • Number of events 2
|
0.00%
0/36
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/36
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/37
|
0.00%
0/35
|
2.8%
1/36 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/37
|
0.00%
0/35
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/37
|
0.00%
0/35
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Dizziness
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/36
|
0.00%
0/40
|
|
Nervous system disorders
Syncope
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/36
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Surgical and medical procedures
Internal fixation of fracture
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place