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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02293187
Recruitment Status : Completed
First Posted : November 18, 2014
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Bess Dawson-Hughes, Tufts University

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Sarcopenia Dietary Supplement: vitamin D3 Other: Placebo Not Applicable

Detailed Description:
Vitamin D may have favorable effects on muscle but evidence is mixed. It appears that subjects with low starting levels of 25-hydroxyvitamin D (25OHD) who receive adequate doses of vitamin D are the most likely to benefit. Vitamin D supplements are being widely recommended, however the amount of vitamin D needed to achieve the desired level of 25-hydroxyvitamin D in the circulation varies widely among individuals. In this randomized, placebo-controlled trial, we will determine whether treating older adults with low starting 25OHD levels for one year with up to 1600 IU per day of vitamin D3 will improve muscle performance (e.g., lower extremity muscle power) and reduce muscle wasting (defined as reducing nitrogen excretion). Subjects in the vitamin D group will initially take 800 IU of vitamin D3 daily. If they have not achieved the desired level of 70 nmol/L after 4 mo, their dose will be doubled to 1600 IU per day for the remainder of the one-year study. The maximal dose of vitamin D3 to be taken in this study,1600 IU per day, is lower than the current safe upper limit of 4,000 IU per day set by the Institute of Medicine. Up to 100 healthy men and women, age 60 years and older will participate in this study. This investigation should increase our understanding of the impact of supplemental vitamin D on muscle performance.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Impact of Supplemental Vitamin D on Serum 25-hydroxyvitamin D Levels and Short Term Indicators of Physical Function
Actual Study Start Date : March 23, 2015
Actual Primary Completion Date : September 13, 2017
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: vitamin D3
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
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.
Other Name: cholecalciferol

Placebo Comparator: Placebo
Placebo, microcrystalline cellulose
Other: Placebo
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.
Other Name: microcystalline cellulose




Primary Outcome Measures :
  1. The effect of supplemental vitamin D3 vs placebo on leg power and nitrogen excretion. [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. To describe the safety (assessed by serum calcium) of the administered doses of vitamin D3. [ Time Frame: 12 months ]
    To describe the safety (assessed by serum calcium) of the administered doses of vitamin D3.


Other Outcome Measures:
  1. To determine the effect of supplemental vitamin D3 vs placebo on SPPB. [ Time Frame: 12 months ]
    To determine the effect of supplemental vitamin D3 vs placebo on SPPB.

  2. To determine the effect of supplemental vitamin D3 vs placebo on handgrip. [ Time Frame: 12 months ]
    To determine the effect of supplemental vitamin D3 vs placebo on handgrip.

  3. To determine the effect of supplemental vitamin D3 vs placebo on stair climb. [ Time Frame: 12 months ]
    To determine the effect of supplemental vitamin D3 vs placebo on stair climb.

  4. To determine the effect of supplemental vitamin D3 vs placebo on backward walking. [ Time Frame: 12 months ]
    To determine the effect of supplemental vitamin D3 vs placebo on backward walking.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • Non-English speaking subjects (We can't be confident that non-English speaking subjects could accurately identify intakes of calcium and vitamin D from non-study sources and this could increase their risk of toxicity from study drug.
  • Other abnormalities in screening labs, at the discretion of the study physician (the PI)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293187


Locations
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United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Investigators
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Principal Investigator: Bess Dawson-Hughes, MD Tufts Medical Center
Publications:
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Responsible Party: Bess Dawson-Hughes, Director, Bone Metabolism Laboratory, HNRCA, Tufts University
ClinicalTrials.gov Identifier: NCT02293187    
Other Study ID Numbers: 2710
First Posted: November 18, 2014    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Bess Dawson-Hughes, Tufts University:
vitamin D
muscle performance
falls
Additional relevant MeSH terms:
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Sarcopenia
Vitamin D Deficiency
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents