Trial Outcomes & Findings for Improving Vitamin D Status in Home-bound Elders (NCT NCT01410084)

Last Updated: 2019-09-09

Results Overview

Determine the effectiveness of the intervention on improving 25-hydroxyvitamin D levels (change in 25(OH)D from baseline to 5-month follow-up). Measured as 5-month follow-up 25(OH)D level minus baseline 25(OH)D level.

Recruitment status

COMPLETED

Study phase

Target enrollment

68 participants

Primary outcome timeframe

5 months

Results posted on

2019-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	Vitamin D3 100,000 IU vitamin D3 once monthly Vitamin D3: 100,000 IU vitamin D3 once monthly for 5 months	Vitamin E 400 IU vitamin E once monthly Vitamin E: 400 IU vitamin E once monthly for 5 months
Overall Study STARTED	38	30
Overall Study COMPLETED	37	27
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Vitamin D Status in Home-bound Elders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D3 n=38 Participants 100,000 IU vitamin D3 once monthly Vitamin D3: 100,000 IU vitamin D3 once monthly for 5 months	Vitamin E n=30 Participants 400 IU vitamin E once monthly Vitamin E: 400 IU vitamin E once monthly for 5 months	Total n=68 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	38 Participants n=5 Participants	30 Participants n=7 Participants	68 Participants n=5 Participants
Age, Continuous	77.6 years STANDARD_DEVIATION 9.0 • n=5 Participants	78.2 years STANDARD_DEVIATION 8.4 • n=7 Participants	77.9 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	19 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 months

Population: Participants who did not have a 5 month follow-up visit (n=4) and those who did not have baseline and/or follow-up blood samples (n=7) were excluded from the analysis leaving an analysis sample of 57 participants

Outcome measures

Outcome measures
Measure	Vitamin E n=24 Participants 400 IU vitamin E once monthly Vitamin E: 400 IU vitamin E once monthly for 5 months	Vitamin D3 n=33 Participants 100,000 IU vitamin D3 once monthly Vitamin D3: 100,000 IU vitamin D3 once monthly for 5 months
Change in 25-hydroxyvitamin D Levels Over 5 Months	0 ng/mL Standard Error 4.0	21.7 ng/mL Standard Error 3.1

SECONDARY outcome

Timeframe: 5 months

Determine the effectiveness of the intervention on reducing the number of falls using monthly fall calendars (compare the average number of falls in vitamin D3 group vs. active placebo group over 5 months)

Outcome measures

Outcome measures
Measure	Vitamin E n=26 Participants 400 IU vitamin E once monthly Vitamin E: 400 IU vitamin E once monthly for 5 months	Vitamin D3 n=33 Participants 100,000 IU vitamin D3 once monthly Vitamin D3: 100,000 IU vitamin D3 once monthly for 5 months
Number of Falls	1.1 falls/participant Interval 0.0 to 8.0	0.5 falls/participant Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 5 months

Population: Compliance assessed in participants who remained in the study over the 5 month intervention for an analysis sample of 64 participants.

Number of participants who consumed at least 4 out of a possible 5 supplement doses (=\>80% compliance) over 5 months.

Outcome measures

Outcome measures
Measure	Vitamin E n=27 Participants 400 IU vitamin E once monthly Vitamin E: 400 IU vitamin E once monthly for 5 months	Vitamin D3 n=37 Participants 100,000 IU vitamin D3 once monthly Vitamin D3: 100,000 IU vitamin D3 once monthly for 5 months
Number of Participants Who Were Compliant to Intervention	24 Participants	37 Participants

Adverse Events

Vitamin D3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vitamin E

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Denise Houston

Wake Forest School of Medicine

Phone: 336-713-8558

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place