Impact of Vitamin D on 25-hydroxyvitamin D Levels and Physical Function

NCT02293187 | Completed

• 1 other identifier: 2710
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This one-year study will test the hypothesis that supplementation with vitamin D will improve lower extremity muscle performance in older men and women with vitamin D insufficiency.

Conditions

Vitamin D Deficiency; Sarcopenia

Keywords

vitamin D; muscle performance; falls

Outcome Measures

Primary Outcomes (1)

• The effect of supplemental vitamin D3 vs placebo on leg power and nitrogen excretion.

  Aim of the study is to look at the effect of supplemental vitamin D3 vs placebo on leg power and nitrogen excretion.To determine Vitamin D will improve leg power and reduce muscle wasting, as measured by 24-hr nitrogen excretion.

  12 months

Secondary Outcomes (1)

• To describe the safety (assessed by serum calcium) of the administered doses of vitamin D3.

  12 months

Other Outcomes (4)

• To determine the effect of supplemental vitamin D3 vs placebo on SPPB.

  12 months

• To determine the effect of supplemental vitamin D3 vs placebo on handgrip.

  12 months

• To determine the effect of supplemental vitamin D3 vs placebo on stair climb.

  12 months

Study Arms (2)

vitamin D3

ACTIVE COMPARATOR

Vitamin D3, 800 IU will be given initially; after 4 months if D level \< 70 nmol/L, increase dose to 1600 IU for remainder of study.

Dietary Supplement: vitamin D3

Placebo

PLACEBO COMPARATOR

Placebo, microcrystalline cellulose

Other: Placebo

Interventions

vitamin D3 DIETARY_SUPPLEMENT

Dose for intervention arm is 800 IU/day for first 4 months. At 4 months, if vitamin D level \<70 nmol/L, a second 800 IU capsule will be added to regimen (total of 1600 IU/d) for remainder of study.

Also known as: cholecalciferol

vitamin D3

Placebo OTHER

Those in the placebo group will receive 1 capsule for first 4 months. At 4 month visit, one capsule will be added to regimen to be taken throughout the remainder of the study.

Also known as: microcystalline cellulose

Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and postmenopausal women age 60 years and older
• Women must be at least 1 year since last menses.
• Subjects must agree not to take their own vitamin D in amounts \>600 IU/day (for ages 51-70 years) or \>800 IU/day (for ages 71 - 80 years) or more than 600 mg/day of supplemental calcium.
• Subjects must agree not to have had more than 30 minutes/day of sun exposure at a southern latitude (\< 34 degrees N) in the 2-month period prior to screening and not to travel south and be exposed to sunshine in the 3-month period prior to their final visit.
• They will agree not to use tanning salons during the study.
• Screening serum 25OHD of 20 to 50 nmol/L (8.0 to 20 ng/ml).

You may not qualify if:

• Kidney stones - in the last 3 years
• Calculated glomerular filtration rate \< 30 ml/min
• Screening fasting spot urinary calcium:creatinine ratio (Ca:Cr) \> 0.325 (corresponding to a 24-hr urine calcium of 350 mg)
• Serum calcium exceeding upper normal limit (reference range 8.3 -10.2 mg/dl)
• Other abnormalities in screening labs, at the discretion of the study physician (PI)
• Sarcoidosis
• Evidence of chronic liver disease, including alcoholism
• Cancer treatment in the last year (except basal cell carcinoma) or terminal illness
• Treatment in the last 6 months with estrogen, raloxifene, calcitonin, or testosterone (vaginal estrogen use okay)
• High dose thiazide therapy (\>37.5 mg).
• Treatment in the last year with teriparatide or denosumab
• Treatment in the lsat 2 years with bisphosphonates
• Oral corticosteroid therapy for over 3 weeks within the last 6 months
• Anticonvulsant therapy
• Physical conditions such as osteoarthritis, rheumatoid arthritis, heart failure or hemiplegia severe enough to prevent reasonable physical activity.

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• Shea MK, Fielding RA, Dawson-Hughes B. The effect of vitamin D supplementation on lower-extremity power and function in older adults: a randomized controlled trial. Am J Clin Nutr. 2019 Feb 1;109(2):369-379. doi: 10.1093/ajcn/nqy290.

  PMID: 30715090 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency; Sarcopenia

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Bess Dawson-Hughes, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Bone Metabolism Laboratory, HNRCA

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: November 18, 2014
• Study Start: March 23, 2015
• Primary Completion: September 13, 2017
• Study Completion: December 31, 2018
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)