Improving Vitamin D Status in Home-bound Elders

NCT01410084 | Completed Results DMC

• 1 other identifier: IRB00014152
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Accidental Falls

Keywords

vitamin D; falls; deficiency; insufficiency

Outcome Measures

Primary Outcomes (1)

• 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.

  5 months

Secondary Outcomes (2)

• Number of Falls

  5 months

• Number of Participants Who Were Compliant to Intervention

  5 months

Study Arms (2)

Vitamin D3

EXPERIMENTAL

100,000 IU vitamin D3 once monthly

Dietary Supplement: Vitamin D3

Vitamin E

PLACEBO COMPARATOR

400 IU vitamin E once monthly

Dietary Supplement: Vitamin E

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

100,000 IU vitamin D3 once monthly for 5 months

Vitamin D3

Vitamin E DIETARY_SUPPLEMENT

400 IU vitamin E once monthly for 5 months

Vitamin E

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol; Vitamin E

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Denise Houston
• Organization: Wake Forest School of Medicine

dhouston@wakehealth.edu

336-713-8558

Study Officials

• Denise K Houston, PhD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 4, 2011
• Study Start: October 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 9, 2019
• Results First Posted: September 9, 2019

Record last verified: 2019-07

Locations

US (1)