Improving Functionality in Older People

NCT03611049 | Terminated Phase 2 DMC

• 1 other identifier: L18-111
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The study will examine if overall functionality of older adults with Vitamin D insufficiency can be improved by optimal Vitamin D replacement over a period of approximately one year. A variety of outcome metrics will be examined including mental and physical parameters

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (6)

• Muscle Strength

  Muscle strength will be determined by hand grip

  1 year

• Gait speed

  Gait speed will be determined by timed walking

  1 year

• Hippocampal and brain volumes

  Using a 3 Tesla MRI scanner using FreeSurfer software. Brain volumes are estimated in cubic centimeters and hippocampal volumes are estimated in cubic millimeters

  1 year

• Body composition and regional fat distribution

  Body composition will be determined by bioelectrical impedance. Regional fat distribution will be assessed by waist hip ratio. Obesity will be determined through body mass index and percent body fat estimation through bioelectrical impedance

  1 year

• Cognition

  Using a battery of tests from Cambridge Cognition. Each test will be given an equal value and a composite cognitive score determined by summation

  1 year

• Quality of Life questionnaire

  Quality of life will be determined by SF-36 Questionnaire by Rand

  1 year

Study Arms (2)

Low dose Vitamin D intervention

PLACEBO COMPARATOR

intervention includes 800 IU Vitamin D3 replacement

Dietary Supplement: Low dose Vitamin D3

High dose Vitamin D intervention

ACTIVE COMPARATOR

Intervention includes 5000 IU Vitamin D3 replacement

Dietary Supplement: High dose Vitamin D3

Interventions

High dose Vitamin D3 DIETARY_SUPPLEMENT

High dose arm- 5000IU given daily

High dose Vitamin D intervention

Low dose Vitamin D3 DIETARY_SUPPLEMENT

Low dose arm-800 IU given daily

Low dose Vitamin D intervention

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Community dwelling subject (adults) aged between 65 and 89 years of age
• Subject should be ambulatory and living at home
• Subject should be capable of self-care
• Subject should be able to drive an automobile independently and without assistance
• Subject should agree to home visitation by CRI coordinators to assess pill counts or willing to come to TTUHSC for such a visit
• (OH) Vitamin D value \< 30 ng/ml

You may not qualify if:

• Participant unable or unwilling to have follow up for the duration of the study
• Subject that cannot take a daily supplement
• Subject unable to have MRI imaging
• Subject on peritoneal or hemodialysis
• Subject unwilling to have multiple blood draws
• Subject with Sarcoidosis or diseases associated with hypercalcemia
• Subject currently taking supplements containing Vitamin D
• Subject with prior cerebrovascular disease or memory problems
• Subject with prior myocardial infarction or atrial fibrillation or on anticoagulants
• Subject on medications for memory or cognitive issues or mental ill-health
• Subject with life expectancy less than 2 years
• Subject receiving assistance for self-care
• Subject cannot pass motor screening test for valid assessment of cognition
• Subject on medications for Diabetes
• Subject on medication for hypertension

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel interventions in subjects with vitamin D insufficiency. A low dose vitamin D replacement arm and a high dose vitamin D replacement arm

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: August 2, 2018
• Study Start: August 1, 2018
• Primary Completion: July 19, 2019
• Study Completion: July 19, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)