Trial Outcomes & Findings for High Dose Vitamin D vs Standard Dose Vitamin D Study (NCT NCT01988090)

NCT ID: NCT01988090

Last Updated: 2021-08-09

Results Overview

Aromatase Inhibitor Arthralgia (AIA) was assessed by a questionnaire that describe the level of pain experienced by the participant. The questionnaire asks 20 questions scored 0-3 in 8 categories of functioning: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. An average composite score on the HAQ-II was calculated. The visual analog scale is the other major component of the HAQ-II, which we ask patients to mark where their pain lies on a horizontal line and we converts the number into a score from 0 to 3. For the purposes of this study, AIA will be defined as any of the following criteria: 1) increase in HAQ-II score from baseline by 0.2 or greater; or 2) increase in visual analog pain score by 0.3 or greater.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

93 participants

Primary outcome timeframe

12 weeks

Results posted on

2021-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	High Dose Vitamin D ARM 50,000 IU Vitamin D supplement 50,000 IU Vitamin D supplement: High Dose	800 IU Vitamin D Supplement 800 IU Vitamin D Supplement 800 IU Vitamin D Supplement: Standard Dose
Start Treament After Randomization STARTED	46	47
Start Treament After Randomization COMPLETED	44	43
Start Treament After Randomization NOT COMPLETED	2	4
Complete Study After Start STARTED	44	43
Complete Study After Start COMPLETED	41	42
Complete Study After Start NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	High Dose Vitamin D ARM 50,000 IU Vitamin D supplement 50,000 IU Vitamin D supplement: High Dose	800 IU Vitamin D Supplement 800 IU Vitamin D Supplement 800 IU Vitamin D Supplement: Standard Dose
Start Treament After Randomization Withdrawal by Subject	2	3
Start Treament After Randomization Protocol Violation	0	1
Complete Study After Start Withdrawal by Subject	2	0
Complete Study After Start Protocol Violation	1	1

Baseline Characteristics

High Dose Vitamin D vs Standard Dose Vitamin D Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Dose Vitamin D ARM n=46 Participants 50,000 IU Vitamin D supplement 50,000 IU Vitamin D supplement: High Dose	800 IU Vitamin D Supplement n=47 Participants 800 IU Vitamin D Supplement 800 IU Vitamin D Supplement: Standard Dose	Total n=93 Participants Total of all reporting groups
Age, Continuous	62.9 years STANDARD_DEVIATION 7 • n=93 Participants	63.8 years STANDARD_DEVIATION 8.6 • n=4 Participants	63.4 years STANDARD_DEVIATION 7.8 • n=27 Participants
Sex: Female, Male Female	46 Participants n=93 Participants	47 Participants n=4 Participants	93 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=93 Participants	22 Participants n=4 Participants	41 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=93 Participants	24 Participants n=4 Participants	50 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	11 Participants n=93 Participants	6 Participants n=4 Participants	17 Participants n=27 Participants
Race (NIH/OMB) White	33 Participants n=93 Participants	39 Participants n=4 Participants	72 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment United States	46 participants n=93 Participants	47 participants n=4 Participants	93 participants n=27 Participants
Serum 25-hydroxyvitamin D level	21.7 ng/mL STANDARD_DEVIATION 8.7 • n=93 Participants	24.2 ng/mL STANDARD_DEVIATION 7.1 • n=4 Participants	23 ng/mL STANDARD_DEVIATION 8 • n=27 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: ITT population. All patients who were randomized in the study were included in the overall evaluation of response (intent-to-treat analysis).

Outcome measures

Outcome measures
Measure	High Dose Vitamin D ARM n=46 Participants 50,000 IU Vitamin D supplement 50,000 IU Vitamin D supplement: High Dose	800 IU Vitamin D Supplement n=47 Participants 800 IU Vitamin D Supplement 800 IU Vitamin D Supplement: Standard Dose
Number of Participants With Aromatase Inhibitor Induced Arthralgia (AIA) After 12 Weeks of Therapy no development of AIA	21 Participants	20 Participants
Number of Participants With Aromatase Inhibitor Induced Arthralgia (AIA) After 12 Weeks of Therapy development of AIA	25 Participants	27 Participants

SECONDARY outcome

Timeframe: 52 Weeks

Population: Compliance was assessed at week 52. Only 14 patients have compete the data collection. Form was not completed due to not starting the treatment, or not finishing the treatment, or no source data.

We checked compliance of aromatase inhibitor therapy during the study by reviewing the patient's use of AI drug. This will be done by counting remaining pills in patient's bottles of AI at 52 weeks. A percentage of the number of pills were actually taken of the number of pills should be taken was calculated.

Outcome measures

Outcome measures
Measure	High Dose Vitamin D ARM n=6 Participants 50,000 IU Vitamin D supplement 50,000 IU Vitamin D supplement: High Dose	800 IU Vitamin D Supplement n=8 Participants 800 IU Vitamin D Supplement 800 IU Vitamin D Supplement: Standard Dose
Compliance With Anti-Cancer Treatment	0.981 percentage of pills taken Standard Deviation 0.047	0.965 percentage of pills taken Standard Deviation 0.07

SECONDARY outcome

Timeframe: 12 weeks

Population: Patients who had serum 25-hydroxyvitamin D level tested at baseline and week 12 were included in the analysis.

Patients' serum 25-hydroxyvitamin D level were tested at baseline and week 12. The changes between baseline and week 12 were calculated.

Outcome measures

Outcome measures
Measure	High Dose Vitamin D ARM n=39 Participants 50,000 IU Vitamin D supplement 50,000 IU Vitamin D supplement: High Dose	800 IU Vitamin D Supplement n=36 Participants 800 IU Vitamin D Supplement 800 IU Vitamin D Supplement: Standard Dose
Association Between Vitamin D Levels Changes and Treatment.	28.8 ng/mL Standard Deviation 14.5	5.2 ng/mL Standard Deviation 7.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 52 weeks

Exploratory Endpoints For each patient on the study, grip strength will be correlated with AIA score using Spearman correlation at three time points throughout the study - baseline, week 12, and week 52.

Outcome measures

Outcome data not reported

Adverse Events

High Dose Vitamin D ARM

Serious events: 2 serious events

Other events: 35 other events

Deaths: 0 deaths

800 IU Vitamin D Supplement

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	High Dose Vitamin D ARM n=44 participants at risk 50,000 IU Vitamin D supplement 50,000 IU Vitamin D supplement: High Dose	800 IU Vitamin D Supplement n=43 participants at risk 800 IU Vitamin D Supplement 800 IU Vitamin D Supplement: Standard Dose
Infections and infestations Skin infection	2.3% 1/44 • Number of events 1 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	0.00% 0/43 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Renal and urinary disorders Renal and urinary disorders - Other, specify	2.3% 1/44 • Number of events 1 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	0.00% 0/43 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.

Other adverse events

Additional Information

Tao Wang

Baylor College of Medicine

Phone: 7137985388

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	High Dose Vitamin D ARM n=44 participants at risk 50,000 IU Vitamin D supplement 50,000 IU Vitamin D supplement: High Dose	800 IU Vitamin D Supplement n=43 participants at risk 800 IU Vitamin D Supplement 800 IU Vitamin D Supplement: Standard Dose
Endocrine disorders Hypothyroidism	4.5% 2/44 • Number of events 2 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	0.00% 0/43 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Gastrointestinal disorders Constipation	6.8% 3/44 • Number of events 3 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	2.3% 1/43 • Number of events 1 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Gastrointestinal disorders Diarrhea	4.5% 2/44 • Number of events 2 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	0.00% 0/43 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Gastrointestinal disorders Gastroesophageal reflux disease	2.3% 1/44 • Number of events 1 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	4.7% 2/43 • Number of events 2 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
General disorders Fatigue	13.6% 6/44 • Number of events 6 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	9.3% 4/43 • Number of events 4 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
General disorders Pain	4.5% 2/44 • Number of events 2 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	2.3% 1/43 • Number of events 1 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	45.5% 20/44 • Number of events 25 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	44.2% 19/43 • Number of events 22 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Musculoskeletal and connective tissue disorders Arthritis	4.5% 2/44 • Number of events 2 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	2.3% 1/43 • Number of events 1 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/44 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	7.0% 3/43 • Number of events 3 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Musculoskeletal and connective tissue disorders Neck pain	4.5% 2/44 • Number of events 2 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	0.00% 0/43 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	4.5% 2/44 • Number of events 2 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	16.3% 7/43 • Number of events 7 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Nervous system disorders headache	4.5% 2/44 • Number of events 2 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	2.3% 1/43 • Number of events 1 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Nervous system disorders Peripheral sensory neuropathy	20.5% 9/44 • Number of events 12 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	2.3% 1/43 • Number of events 1 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Psychiatric disorders Anxiety	0.00% 0/44 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	7.0% 3/43 • Number of events 3 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Psychiatric disorders Depression	9.1% 4/44 • Number of events 4 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	7.0% 3/43 • Number of events 3 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Psychiatric disorders Insomnia	2.3% 1/44 • Number of events 1 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	7.0% 3/43 • Number of events 3 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Reproductive system and breast disorders vaginal dryness	11.4% 5/44 • Number of events 5 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	7.0% 3/43 • Number of events 4 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	4.5% 2/44 • Number of events 2 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	0.00% 0/43 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Vascular disorders Hot flashes	52.3% 23/44 • Number of events 25 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	46.5% 20/43 • Number of events 22 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.
Vascular disorders Hypertension	9.1% 4/44 • Number of events 4 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.	2.3% 1/43 • Number of events 1 • 56 weeks. Adverse events experienced by participants were collected and reported from initiation of study medication, throughout the study (52 weeks treatment), and within 30 days of the last dose of study medication.