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Improving Vitamin D Status in Home-bound Elders

Improving Vitamin D Status in Home-bound Elders: a Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01410084
Acronym
MOW VitD
Enrollment
68
Registered
2011-08-04
Start date
2010-10-31
Completion date
2011-08-31
Last updated
2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Falls, Vitamin D Deficiency

Keywords

vitamin D, falls, deficiency, insufficiency

Brief summary

In the past two decades, the role of vitamin D has extended beyond bone health to encompass a wide range of biological activities important to physical function in older adults. A growing body of evidence now shows that circulating 25-hydroxyvitamin D (25(OH)D) levels \< 75 nmol/L (\< 30 ng/mL)) are associated with physical impairments such as reduced walking speed and impaired balance as well as falls. Older adults are at risk for low levels of 25-hydroxyvitamin D because of reduced exposure to ultraviolet B radiation, reduced efficiency of previtamin D synthesis in the skin, and low dietary intake. Although data from the National Health and Nutrition Examination Survey (NHANES) 2000-2004 indicate that frank vitamin D deficiency (serum 25(OH)D \< 25 nmol/L \[10 ng/mL\]) is rare in the U.S. (5% or less), vitamin D insufficiency (serum 25(OH)D \< 75 nmol/L \[30 ng/mL\]) is prevalent (\ 75%) among older adults. Older home-bound adults are a vulnerable subgroup of older adults for poor dietary intake and nutritional health, nutrition-related health conditions, and functional decline and disability. The primary goal of this pilot study is to assess the feasibility of a partnership with Senior Services of Forsyth County to address vitamin D insufficiency in home-bound older adults receiving home-delivered meals. A secondary goal is to obtain preliminary data on the effectiveness of vitamin D supplementation on improving vitamin D levels and reducing falls.

Detailed description

In the past two decades, the role of vitamin D has extended beyond bone health to encompass a wide range of biological activities important to physical function in older adults. A growing body of evidence now shows that circulating 25-hydroxyvitamin D (25(OH)D) levels \< 75 nmol/L (\< 30 ng/mL)) are associated with physical impairments such as reduced walking speed and impaired balance as well as falls. Older adults are at risk for low levels of 25-hydroxyvitamin D because of reduced exposure to ultraviolet B radiation, reduced efficiency of previtamin D synthesis in the skin, and low dietary intake. Although data from the National Health and Nutrition Examination Survey (NHANES) 2000-2004 indicate that frank vitamin D deficiency (serum 25(OH)D \< 25 nmol/L \[10 ng/mL\]) is rare in the U.S. (5% or less), vitamin D insufficiency (serum 25(OH)D \< 75 nmol/L \[30 ng/mL\]) is prevalent (\ 75%) among older adults. Older home-bound adults are a vulnerable subgroup of older adults for poor dietary intake and nutritional health, nutrition-related health conditions, and functional decline and disability. The primary goal of this pilot study is to assess the feasibility of a partnership with Senior Services of Forsyth County to address vitamin D insufficiency in home-bound older adults receiving home-delivered meals. The investigators will accomplish this goal by conducting a 5-month randomized, controlled trial in 200 older Meals-on-Wheels (MOW) recipients randomized to receive monthly either (1) 100,000 IU vitamin D3 or (2) an active placebo (vitamin E) to achieve the following specific aims: Aim 1: Determine the prevalence of falls and risk of vitamin D insufficiency in 200 MOW recipients. Aim 2: Assess the feasibility of the vitamin D intervention delivered through the MOW program. Aim 3: Obtain preliminary data on the effectiveness of the intervention on improving vitamin D status and reducing falls. Data from this pilot study will: 1) provide estimates of the prevalence of falls and vitamin D insufficiency in home-bound older adults participating in the Forsyth County MOW program; 2) provide estimates of participant compliance and drop-out to a vitamin supplementation trial delivered as part of the MOW program; 3) provide evidence for the efficacy of the vitamin D dose proposed in remediating vitamin D insufficiency; and 4) provide preliminary data on the potential benefit of vitamin D supplementation on falls in a home-bound older population.

Interventions

DIETARY_SUPPLEMENTVitamin D3

100,000 IU vitamin D3 once monthly for 5 months

DIETARY_SUPPLEMENTVitamin E

400 IU vitamin E once monthly for 5 months

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 65 years old * Forsyth County Senior Services Meals-on-Wheels recipient * Willing to provide informed consent * Willing to be randomized to vitamin D or active placebo control

Exclusion criteria

* Hyperparathyroidism * Kidney stones (within the past 2 years) * History of hypercalcemia * On dialysis * Inability or contraindications to consume vitamin D supplements * Taking prescription vitamin D2 or vitamin D3-containing supplements totaling \> 1000 IU/d * Planning to move within the next 6 months

Design outcomes

Primary

MeasureTime frameDescription
Change in 25-hydroxyvitamin D Levels Over 5 Months5 monthsDetermine 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.

Secondary

MeasureTime frameDescription
Number of Falls5 monthsDetermine 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)
Number of Participants Who Were Compliant to Intervention5 monthsNumber of participants who consumed at least 4 out of a possible 5 supplement doses (=\>80% compliance) over 5 months.

Countries

United States

Participant flow

Participants by arm

ArmCount
Vitamin D3
100,000 IU vitamin D3 once monthly Vitamin D3: 100,000 IU vitamin D3 once monthly for 5 months
38
Vitamin E
400 IU vitamin E once monthly Vitamin E: 400 IU vitamin E once monthly for 5 months
30
Total68

Baseline characteristics

CharacteristicVitamin D3Vitamin ETotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
38 Participants30 Participants68 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous77.6 years
STANDARD_DEVIATION 9
78.2 years
STANDARD_DEVIATION 8.4
77.9 years
STANDARD_DEVIATION 8.7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
27 Participants24 Participants51 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
11 Participants6 Participants17 Participants
Sex: Female, Male
Female
30 Participants19 Participants49 Participants
Sex: Female, Male
Male
8 Participants11 Participants19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 383 / 30
other
Total, other adverse events
0 / 380 / 30
serious
Total, serious adverse events
0 / 380 / 30

Outcome results

Primary

Change in 25-hydroxyvitamin D Levels Over 5 Months

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.

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
Vitamin D3Change in 25-hydroxyvitamin D Levels Over 5 Months21.7 ng/mLStandard Error 3.1
Vitamin EChange in 25-hydroxyvitamin D Levels Over 5 Months0 ng/mLStandard Error 4
Secondary

Number of Falls

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)

Time frame: 5 months

ArmMeasureValue (MEAN)
Vitamin D3Number of Falls0.5 falls/participant
Vitamin ENumber of Falls1.1 falls/participant
Secondary

Number of Participants Who Were Compliant to Intervention

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

Time frame: 5 months

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Vitamin D3Number of Participants Who Were Compliant to Intervention37 Participants
Vitamin ENumber of Participants Who Were Compliant to Intervention24 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026