Trial Outcomes & Findings for Vitamin D Levels in Stage IV Colorectal Cancer Patients (NCT NCT01074216)
NCT ID: NCT01074216
Last Updated: 2016-02-03
Results Overview
To determine the ability of achieving the target serum 25-hydroxy vitamin D level of 40 ng/ml within 6 weeks of beginning vitamin D supplements in patients with metastatic colon cancer. A response is defined as achieving serum vitamin D levels ≥40 ng/ml at least once at any point during the first 6 weeks
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Within 6 weeks of beginning vitamin D
Results posted on
2016-02-03
Participant Flow
Participant milestones
| Measure |
All Patients
Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
All Patients
Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Not Treated
|
12
|
Baseline Characteristics
Vitamin D Levels in Stage IV Colorectal Cancer Patients
Baseline characteristics by cohort
| Measure |
All Patients
n=54 Participants
Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Within 6 weeks of beginning vitamin DTo determine the ability of achieving the target serum 25-hydroxy vitamin D level of 40 ng/ml within 6 weeks of beginning vitamin D supplements in patients with metastatic colon cancer. A response is defined as achieving serum vitamin D levels ≥40 ng/ml at least once at any point during the first 6 weeks
Outcome measures
| Measure |
All Patients
n=41 Participants
Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
|
|---|---|
|
To Achieve Target Vitamin D Level
|
41 participants
|
Adverse Events
All Patients
Serious events: 13 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=54 participants at risk
Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
|
|---|---|
|
General disorders
Abdominal pain
|
3.7%
2/54 • Number of events 2
|
|
General disorders
Allergic reaction
|
1.9%
1/54 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
3.7%
2/54 • Number of events 2
|
|
General disorders
Anorexia
|
1.9%
1/54 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
1.9%
1/54 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
1.9%
1/54 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/54 • Number of events 1
|
|
General disorders
Death NOS
|
3.7%
2/54 • Number of events 2
|
|
Gastrointestinal disorders
Dehydration
|
3.7%
2/54 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
1/54 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.9%
1/54 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.7%
2/54 • Number of events 2
|
|
General disorders
Fatigue
|
1.9%
1/54 • Number of events 1
|
|
General disorders
Febrile neutropenia
|
1.9%
1/54 • Number of events 2
|
|
General disorders
Fever
|
1.9%
1/54 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.9%
1/54 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.9%
1/54 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
1.9%
1/54 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
1/54 • Number of events 1
|
|
Infections and infestations
Infections and infestations
|
1.9%
1/54 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.7%
2/54 • Number of events 2
|
|
Gastrointestinal disorders
Obstruction gastric
|
1.9%
1/54 • Number of events 1
|
|
General disorders
Pain
|
1.9%
1/54 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
1/54 • Number of events 1
|
|
Infections and infestations
Prostate infection
|
1.9%
1/54 • Number of events 1
|
|
Renal and urinary disorders
Renal and urinary disorders
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.9%
1/54 • Number of events 1
|
|
General disorders
Surgical and medical procedures - Other
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
1.9%
1/54 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract infection
|
3.7%
2/54 • Number of events 3
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/54 • Number of events 1
|
Other adverse events
| Measure |
All Patients
n=54 participants at risk
Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
|
|---|---|
|
General disorders
Abdominal pain
|
14.8%
8/54
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
11.1%
6/54
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
16.7%
9/54
|
|
General disorders
Anorexia
|
9.3%
5/54
|
|
Psychiatric disorders
Anxiety
|
5.6%
3/54
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
13.0%
7/54
|
|
Metabolism and nutrition disorders
Blood bilirubin increased
|
14.8%
8/54
|
|
Gastrointestinal disorders
Constipation
|
7.4%
4/54
|
|
Gastrointestinal disorders
Diarrhea
|
7.4%
4/54
|
|
General disorders
Fatigue
|
25.9%
14/54
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.9%
14/54
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.8%
8/54
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
18.5%
10/54
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.4%
4/54
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
9/54
|
|
Blood and lymphatic system disorders
Prothrombin ratio and international normalized ratio increased
|
13.0%
7/54
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
14.8%
8/54
|
|
General disorders
Mucositis oral
|
11.1%
6/54
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
25.9%
14/54
|
|
General disorders
Pain
|
7.4%
4/54
|
|
General disorders
Pain in extremity
|
5.6%
3/54
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.8%
8/54
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
11.1%
6/54
|
|
General disorders
Surgical and medical procedures - Other
|
7.4%
4/54
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
25.9%
14/54
|
Additional Information
Dr. Barrie Cassileth
Memorial Sloan Kettering Cancer Center
Phone: 646-888-0801
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place