Trial Outcomes & Findings for A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients (NCT NCT00424619)

NCT ID: NCT00424619

Last Updated: 2025-07-16

Results Overview

Serum 25-hydroxyvitamin D3 (25-OHD) was measured at baseline, at discharge from hospital (approximately 4-weeks), and at a follow-up study visit at approximately 3-months.Baseline and 4-week blood samples were drawn in-hospital; venipunctures performed at 3-months were either in-hospital (if patient remained in acute care or rehabilitation) or at the out-patient clinic visit.Serum 25-OHD was analyzed with the DiaSorin, 25-hydroxyvitamin D radioimmunoassay (Stillwater, Minnesota 55082-0285, U.S.A) at the central laboratory with the exception of 3 patients (data analyzed at other laboratories).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 64 participants
• Primary outcome timeframe: Baseline, 4 weeks and 3 months
• Results posted on: 2025-07-16

Participant Flow

Participant milestones

Measure	50 000 IU Vitamin D2 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	100 000 IU Vitamin D2 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	Placebo Placebo at beginning of study and 1000IU vitamin D3 for 90 days
Baseline STARTED	22	22	21
Baseline COMPLETED	22	22	20
Baseline NOT COMPLETED	0	0	1
4 Week STARTED	18	17	17
4 Week COMPLETED	18	17	17
4 Week NOT COMPLETED	0	0	0
3 Month STARTED	12	18	17
3 Month COMPLETED	12	18	17
3 Month NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients

Baseline characteristics by cohort

Measure	50 000 IU Vitamin D2 n=22 Participants 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	100 000 IU Vitamin D2 n=22 Participants 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	Placebo n=20 Participants Placebo at beginning of study and 1000IU vitamin D3 for 90 days	Total n=64 Participants Total of all reporting groups
Age, Continuous	82.9 years STANDARD_DEVIATION 8.7 • n=5 Participants	73.9 years STANDARD_DEVIATION 12.4 • n=7 Participants	78.5 years STANDARD_DEVIATION 10.3 • n=5 Participants	78.43 years STANDARD_DEVIATION 11.09 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants	36 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	14 Participants n=7 Participants	7 Participants n=5 Participants	28 Participants n=4 Participants
Region of Enrollment Canada	22 participants n=5 Participants	22 participants n=7 Participants	20 participants n=5 Participants	64 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 4 weeks and 3 months

Population: Baseline data (n=59) was missing for two participants, and four outliers with 25-OHD taken at 6, 10 or 12 days were not included. 4-week data (n=50) was missing for 13 participants, and two outliers with 25-OHD taken at \<13 days were not included. 3-month data (n=47) was missing for 18 participants.

Serum 25-hydroxyvitamin D3 (25-OHD) was measured at baseline, at discharge from hospital (approximately 4-weeks), and at a follow-up study visit at approximately 3-months.Baseline and 4-week blood samples were drawn in-hospital; venipunctures performed at 3-months were either in-hospital (if patient remained in acute care or rehabilitation) or at the out-patient clinic visit.Serum 25-OHD was analyzed with the DiaSorin, 25-hydroxyvitamin D radioimmunoassay (Stillwater, Minnesota 55082-0285, U.S.A) at the central laboratory with the exception of 3 patients (data analyzed at other laboratories).

Outcome measures

Measure	50 000 IU Vitamin D2 n=20 Participants 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	100 000 IU Vitamin D2 n=21 Participants 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	Placebo n=18 Participants Placebo at beginning of study and 1000IU vitamin D3 for 90 days
25-hydroxyvitamin D3 (25-OHD) Baseline	53.5 nmol/L 95% Confidence Interval 34.8-58.6 • Interval 42.3 to 64.8	58.4 nmol/L Interval 47.3 to 69.5	46.7 nmol/L Interval 34.8 to 58.6
25-hydroxyvitamin D3 (25-OHD) 4-week	84.5 nmol/L Interval 73.7 to 95.3	75.6 nmol/L Interval 64.5 to 86.8	69.3 nmol/L Interval 58.4 to 80.2
25-hydroxyvitamin D3 (25-OHD) 3-month	84.2 nmol/L Interval 73.6 to 94.9	73.3 nmol/L Interval 64.5 to 82.1	86.7 nmol/L Interval 77.6 to 95.9

PRIMARY outcome

Timeframe: Baseline

Baseline blood samples were drawn in-hospital. In additional PTH was accessed at baseline.

Outcome measures

Measure	50 000 IU Vitamin D2 n=22 Participants 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	100 000 IU Vitamin D2 n=22 Participants 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	Placebo n=20 Participants Placebo at beginning of study and 1000IU vitamin D3 for 90 days
Parathyroid Hormone (PTH)	5.35 pmol/L Standard Deviation 3.01	5.10 pmol/L Standard Deviation 3.91	4.2 pmol/L Standard Deviation 2.12

PRIMARY outcome

Timeframe: Baseline, 4 weeks

Baseline blood samples were drawn in-hospital. In additional Calcium was accessed at baseline and approximately 4 weeks.

Outcome measures

Measure	50 000 IU Vitamin D2 n=21 Participants 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	100 000 IU Vitamin D2 n=22 Participants 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	Placebo n=20 Participants Placebo at beginning of study and 1000IU vitamin D3 for 90 days
Calcium Baseline	2.10 mmol/L Standard Deviation 0.14	2.12 mmol/L Standard Deviation 0.11	2.08 mmol/L Standard Deviation 0.14
Calcium 4 Weeks	2.26 mmol/L Standard Deviation 0.17	2.31 mmol/L Standard Deviation 0.11	2.28 mmol/L Standard Deviation 0.15

PRIMARY outcome

Timeframe: Baseline

Baseline blood samples were drawn in-hospital. In additional phosphate was accessed at baseline.

Outcome measures

Measure	50 000 IU Vitamin D2 n=22 Participants 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	100 000 IU Vitamin D2 n=22 Participants 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	Placebo n=20 Participants Placebo at beginning of study and 1000IU vitamin D3 for 90 days
Phosphate	0.86 mmol/L Standard Deviation 0.22	0.97 mmol/L Standard Deviation 0.24	0.94 mmol/L Standard Deviation 0.27

PRIMARY outcome

Timeframe: Baseline

Baseline blood samples were drawn in-hospital. In additional Alkaline Phosphatase was accessed at baseline.

Outcome measures

Measure	50 000 IU Vitamin D2 n=22 Participants 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	100 000 IU Vitamin D2 n=22 Participants 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	Placebo n=20 Participants Placebo at beginning of study and 1000IU vitamin D3 for 90 days
Alkaline Phosphatase	98.6 U/L Standard Deviation 3.78	78.7 U/L Standard Deviation 26.2	79.4 U/L Standard Deviation 51.1

PRIMARY outcome

Timeframe: Baseline

Baseline blood samples were drawn in-hospital. In additional hemoglobin was accessed at baseline.

Outcome measures

Measure	50 000 IU Vitamin D2 n=22 Participants 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	100 000 IU Vitamin D2 n=22 Participants 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	Placebo n=20 Participants Placebo at beginning of study and 1000IU vitamin D3 for 90 days
Hemoglobin	102.2 g/L Standard Deviation 14.3	107.9 g/L Standard Deviation 17.4	108.6 g/L Standard Deviation 15.2

PRIMARY outcome

Timeframe: Baseline

Baseline blood samples were drawn in-hospital. In additional creatinine was accessed at baseline.

Outcome measures

Measure	50 000 IU Vitamin D2 n=22 Participants 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	100 000 IU Vitamin D2 n=22 Participants 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	Placebo n=20 Participants Placebo at beginning of study and 1000IU vitamin D3 for 90 days
Creatinine	70.5 µmol/L Standard Deviation 23.8	77.4 µmol/L Standard Deviation 26.1	73.7 µmol/L Standard Deviation 37

SECONDARY outcome

Timeframe: 3 months

Population: The number of participants who completed the TUG test is lower than the number of participants who completed the primary outcome at this time point. Not everyone chose to complete the functional TUG test at this time point.

The Timed Up and Go (TUG) was collected for patients who attended the 3-month clinic appointment by study coordinators or for patients who attended the rehabilitation unit this is routinely collected and was abstracted from chart. The TUG was conducted using a standard armchair and a line marked 3-metres from the chair. Participants were given the following instructions (no physical assistance was given): "Rise from the chair, walk to the line on the floor, turn, return to the chair and sit down again". Scores are measured as time in seconds to complete the task.

Outcome measures

Measure	50 000 IU Vitamin D2 n=8 Participants 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	100 000 IU Vitamin D2 n=15 Participants 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	Placebo n=11 Participants Placebo at beginning of study and 1000IU vitamin D3 for 90 days
Functional Assessment Using the Timed Up and Go (TUG) Test After 3 Months	26.2 seconds Interval 19.2 to 33.2	19.1 seconds Interval 14.1 to 24.1	18.1 seconds Interval 12.4 to 23.8

SECONDARY outcome

Timeframe: 3 months

Population: The number of participants who completed the 2WT is lower than the number of participants who completed the primary outcome at this time point. Not everyone chose to complete the functional 2WT test at this time point.

The 2MWT was collected for patients who attended the 3-month clinic appointment by study coordinators or for patients who attended rehabilitation, it was abstracted from their charts. The 2MWT test was given in a carpeted corridor and the subject was instructed to wear regular footwear and to use their customary walking aid. The distance the participant could comfortably walk in two-minutes (without physical assistance) was measured in metres.

Outcome measures

Measure	50 000 IU Vitamin D2 n=9 Participants 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	100 000 IU Vitamin D2 n=14 Participants 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	Placebo n=11 Participants Placebo at beginning of study and 1000IU vitamin D3 for 90 days
Functional Assessment Using the Two Minute Walk Test (2MWT)After 3 Months	60.2 meters Interval 41.2 to 79.1	80.3 meters Interval 65.2 to 95.5	63.4 meters Interval 45.4 to 81.5

Adverse Events

50 000 IU Vitamin D2

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

100 000 IU Vitamin D2

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	50 000 IU Vitamin D2 n=22 participants at risk 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	100 000 IU Vitamin D2 n=22 participants at risk 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	Placebo n=20 participants at risk Placebo at beginning of study and 1000IU vitamin D3 for 90 days
Musculoskeletal and connective tissue disorders fractured hip	0.00% 0/22	0.00% 0/22	5.0% 1/20 • Number of events 1
Vascular disorders Pulmonary edmea and Myocardial infarction	0.00% 0/22	4.5% 1/22 • Number of events 1	0.00% 0/20
Surgical and medical procedures gangrenous left foot requiring amputation	0.00% 0/22	4.5% 1/22 • Number of events 1	0.00% 0/20
Respiratory, thoracic and mediastinal disorders Death	4.5% 1/22 • Number of events 1	0.00% 0/22	0.00% 0/20
Cardiac disorders Death	0.00% 0/22	4.5% 1/22 • Number of events 1	0.00% 0/20

Other adverse events

Measure	50 000 IU Vitamin D2 n=22 participants at risk 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	100 000 IU Vitamin D2 n=22 participants at risk 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days	Placebo n=20 participants at risk Placebo at beginning of study and 1000IU vitamin D3 for 90 days
Cardiac disorders Atrial fibrillation	4.5% 1/22 • Number of events 1	0.00% 0/22	0.00% 0/20
Renal and urinary disorders Renal failure	4.5% 1/22 • Number of events 1	0.00% 0/22	0.00% 0/20
Gastrointestinal disorders Diarrhea	4.5% 1/22 • Number of events 1	0.00% 0/22	0.00% 0/20
Musculoskeletal and connective tissue disorders Trip and fall	0.00% 0/22	0.00% 0/22	5.0% 1/20 • Number of events 1
Gastrointestinal disorders Abdominal Distention, nausea, vomiting	0.00% 0/22	0.00% 0/22	5.0% 1/20 • Number of events 1

Additional Information

Dr. Alexandra Papaioannou

McMaster University

Phone: 905-521-2100

Email: papaioannou@hhsc.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place