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

Primary Purpose

Vitamin D Deficiency, Sarcopenia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

vitamin D3

Placebo

About this trial

This is an interventional basic science trial for Vitamin D Deficiency focused on measuring vitamin D, muscle performance, falls

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

vitamin D3

Placebo

Arm Description

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.

Placebo, microcrystalline cellulose

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02293187

First Posted

July 23, 2014

Last Updated

March 19, 2019

Sponsor

Tufts University

1. Study Identification

Unique Protocol Identification Number

NCT02293187

Brief Title

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

Official Title

The Impact of Supplemental Vitamin D on Serum 25-hydroxyvitamin D Levels and Short Term Indicators of Physical Function

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

March 23, 2015 (Actual)

Primary Completion Date

September 13, 2017 (Actual)

Study Completion Date

December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tufts University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency, Sarcopenia

Keywords

vitamin D, muscle performance, falls

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vitamin D3

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo, microcrystalline cellulose

Intervention Type

Dietary Supplement

Intervention Name(s)

vitamin D3

Other Intervention Name(s)

cholecalciferol

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

microcystalline cellulose

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

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

Description

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

Time Frame

12 months

Title

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

Description

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

Time Frame

12 months

Title

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

Description

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

Time Frame

12 months

Title

To determine the effect of supplemental vitamin D3 vs placebo on backward walking.

Description

To determine the effect of supplemental vitamin D3 vs placebo on backward walking.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bess Dawson-Hughes, MD

Organizational Affiliation

Tufts Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30715090

Citation

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.

Results Reference

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

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