Vitamin D's Effect on Physical Performance in the Elderly

NCT02066441 | Completed

• 1 other identifier: 20120195
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare vitamin D deficient and vitamin D sufficient elderly individuals and examine the effect of a vitamin D dietary supplement on serum vitamin D level, bone formation, resorption, and mineral density, flexibility, balance, general inflammation,and quality of life. Enhancing nutritional status is necessary to prevent the continued proliferation of chronic diseases, e.g., bone disease and other chronic disorders thought to now be related to low levels of vitamin D, which are some of the leading disablers and killers of Americans. Americans also have difficulties with compliance to prescription medications due to their toxicity and side effects. This study aims to learn more about how a vitamin D nutritional supplement may improve nutritional status and enable the body to normalize system functioning,which may improve the quality of life for people with vitamin D deficiency. The results of this research will be used to determine if vitamin D is beneficial for overall health among elderly individuals.

Conditions

Family Member

Keywords

Vitamin D; bone formation; resorption; mineral density; inflammation; flexibility; balance; elderly

Outcome Measures

Primary Outcomes (5)

• Change from Baseline in Serum 25-(OH) D level at 6 months

  Vitamin D status defined by serum 25-(OH) D level. All serum measurements need to be taken in the morning following an overnight fast (before 9 AM).

  Baseline, 6 months

• Change from Baseline in Serum parathyroid hormone (PTH) levels at 6 months

  Serum parathyroid hormone (PTH) levels will be measured since serum 25 (OH) D levels corresponding to PTH inflection point are widely interpreted as a marker for vitamin D sufficiency. All serum measurements need to be taken in the morning following an overnight fast (before 9 AM).

  Baseline, 6 months

• Change from Baseline in Serum Osteocalcin at 6 months

  Bone formation as defined by serum osteocalcin. All serum measurements need to be taken in the morning following an overnight fast (before 9 AM).

  Baseline, 6 months

• Change from Baseline in Serum CTX at 6 months

  Bone resorption as defined by serum CTX. All serum measurements need to be taken in the morning following an overnight fast (before 9 AM).

  Baseline, 6 months

• Change from Baseline in Serum C-reactive Protein at 6 months

  General inflammation will be assessed by serum C-reactive protein; a key indicator of multiple inflammatory processes. All serum measurements need to be taken in the morning following an overnight fast (before 9 AM).

  Baseline, 6 months

Secondary Outcomes (20)

• Change from Baseline in Systolic Blood Pressure at 6 months

  Baseline, 6 months

• Change from Baseline in Diastolic Blood Pressure at 6 months

  Baseline, 6 months

• Pulse

  Baseline, 6 months

• Change from Baseline in Gait Velocity at 6 months

  Baseline, 6 months

• Change from Baseline in Step Length at 6 months

  Baseline, 6 months

Study Arms (2)

Bio-D-Mulsion Forte®

EXPERIMENTAL

Bio-D-Mulsion Forte® at a dosage level of 2 drops (4,000 IU) once daily for the 6-month treatment period.

Dietary Supplement: Bio-D-Mulsion Forte®

Placebo

PLACEBO COMPARATOR

Placebo a dosage level of 2 drops once daily for the 6-month treatment period.

Other: Placebo

Interventions

Bio-D-Mulsion Forte® DIETARY_SUPPLEMENT

According to the company's literature, Bio-D-Mulsion Forte® contains: vitamin D (as cholecalciferol), a water and gum Arabic emulsifier base, and sesame oil. This product is documented online at the following web address: http://www.bioticsresearch.com/node/1570

Bio-D-Mulsion Forte®

Placebo OTHER

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ages 55 years and over
• English or Spanish speaking
• Interest in participating in a novel nutritional supplement program
• Willingness to follow recommendations, including going off of all vitamin-D and calcium containing supplements, multivitamins, or OTC medications (e.g., Tums) 2 weeks before starting the study and during the intervention
• Scoring 0-2 errors on the Short Portable Mental Status Questionnaire

You may not qualify if:

• Less than 55 years of age
• Currently enrolled in another research trial for vitamin D dietary supplements or other bone disease treatments
• Unable to consent to the study
• Living in a skilled or intermediate care level nursing facility
• Women who are pregnant, during their period, or less than 2 days before or after their period at the time of the assessment
• Psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, and alcohol or substance abuse/dependence
• Bleeding disorders
• Aphasia or sensory, motor, and/or visual disturbances that could interfere with assessments, including inability to walk 10 feet without a walking aid
• Gastrointestinal disorders that could lead to uncertain resorption of the study supplements
• Major conditions such as neurologic, cardiovascular, pulmonary, renal, endocrine, thyroid, hepatic, autoimmune, or bone/joint that could interfere with vitamin D metabolism, psychometric tests, or body composition assessment (especially renal and heart failure)
• Erratic, accelerated, or mechanically-controlled irregular heart rhythms, atrial fibrillation/flutter, or atrioventricular block or implanted electronic device
• Any condition restricting blood flow, such as severe systemic vascular resistance
• Acute fever, diarrhea, or edema at the time of the assessment
• Dermatological lesions or excessive hair that would be in contact with the placement of the electrodes for the ESC assessment
• Hematologic or oncologic disorders treated with chemotherapy in the previous two years

Sponsors & Collaborators

• University of Miami: lead
• Biotics, Inc.: collaborator

Study Sites (1)

University of Miami Clinical Research Building

Miami, Florida, 33136, United States

Location

Related Publications (2)

• Chandra P, Binongo JN, Ziegler TR, Schlanger LE, Wang W, Someren JT, Tangpricha V. Cholecalciferol (vitamin D3) therapy and vitamin D insufficiency in patients with chronic kidney disease: a randomized controlled pilot study. Endocr Pract. 2008 Jan-Feb;14(1):10-7. doi: 10.4158/EP.14.1.10.

  PMID: 18238736 BACKGROUND

• Vieth R, Chan PC, MacFarlane GD. Efficacy and safety of vitamin D3 intake exceeding the lowest observed adverse effect level. Am J Clin Nutr. 2001 Feb;73(2):288-94. doi: 10.1093/ajcn/73.2.288.

  PMID: 11157326 BACKGROUND

MeSH Terms

Conditions

Inflammation

Interventions

Sugars

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• John Lewis, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 19, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 19, 2015

Record last verified: 2015-05

Locations

US (1)