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Selenium for Musculoskeletal Health

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ClinicalTrials.gov Identifier: NCT02832648
Recruitment Status : Active, not recruiting
First Posted : July 14, 2016
Last Update Posted : June 4, 2019
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
University of Sheffield
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary:

This research aims to determine whether selenium supplements improve bone and muscle health in older women at risk of osteoporosis (low bone density or weak bones) and fracture (broken bones).

Osteoporosis is a major public health problem. One in two women and one in five men over age 50 will have a fracture. Fractures cause pain, disability and reduce life-expectancy. Women with below-average bone density around the time of the menopause might have previously taken hormone replacement (HRT) to prevent osteoporosis, but HRT is much less used now due to side effects. Therefore there is a need for safe, effective and inexpensive preventative interventions for women at risk of osteoporosis.

Selenium is a chemical nutrient present in several human proteins, including anti-oxidants. Anti-oxidants may protect against ageing of tissues, including bone, by mopping up damaging reactive oxygen molecules (sometimes called 'free radicals'). Selenium is present in soil, and so is obtained from many foods. However, soil selenium levels are low in Europe, and dietary intake in the UK is below recommended levels.

We previously found that women with higher blood selenium levels have stronger bones, but this doesn't prove that giving selenium will improve bone strength.

The investigators propose a randomised controlled trial to compare selenium supplements with a placebo (dummy treatment) in women with below-average bone density. The investigators will give selenium (at two different doses) or placebo to 120 women for six months and use blood and urine tests and bone density scans to see if giving selenium does have any effect on bone. The investigators will also do muscle function tests and measurements of free radical molecules.


Condition or disease Intervention/treatment Phase
Osteoporosis Dietary Supplement: selenase (selenium) Phase 3

Detailed Description:

This is a double-blind, randomised, placebo controlled trial. We will evaluate two doses of selenium (50 and 200mcg) vs placebo over six months.

Participants are postmenopausal women with osteopenia or osteoporosis (T-score -1.0 to -3.0).

The investigators will include participants with any baseline serum selenium concentration for generalisability, but the primary endpoint efficacy analysis will only include women with baseline serum selenium below 120 mcg/l.

Primary endpoint: Urinary N-telopeptide of type I collagen (NTX/Cr). Secondary endpoints: other bone turnover markers, BMD, muscle function, thyroid function, blood glucose, anti-oxidant activity, inflammatory markers The investigators will make the primary analysis based on women with baseline serum selenium below 120 mcg/l. To ensure adequate power for this analysis we will plan to recruit 120 women (we expect that 100 of the 120 will have serum selenium below 120 mcg/l based on our previous cross-sectional study). The investigators will review the baseline serum selenium results when 40 women have been recruited to confirm the expected distribution of baseline levels, and we will adjust the total recruitment number accordingly to ensure at least 99 women with serum selenium below 120mcg/l have been randomised for the final primary endpoint intention-to-treat analysis.

Participants will be randomised according to a schedule produced by Sheffield Teaching Hospitals pharmacy according to their standard operating procedure. Randomisation will be carried out independently of the study investigators using block randomisation. The blind will only be broken if judged by the PI as clinically necessary for the wellbeing of a participant.

The study may be stopped early if the investigators, sponsor or DMEC identify a safety concern.

Trial management will be done by the Academic Unit of Bone Metabolism CTIMP group (who meet monthly), and progress reported to the AUBM management group and Lay Panel. We will establish a TSC and DMEC.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Selenium Supplementation on Musculoskeletal Health in Older Women Double-blind, Randomised, Placebo-controlled Trial
Actual Study Start Date : January 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Experimental: selenase 200mcg
selenium as selenase 200mcg once daily, oral
Dietary Supplement: selenase (selenium)
Selenase (Biosyn, Germany) Sodium selenite pentahydrate

Experimental: selenase 50mcg
selenium as selenase 50mcg once daily, oral
Dietary Supplement: selenase (selenium)
Selenase (Biosyn, Germany) Sodium selenite pentahydrate

Placebo Comparator: placebo
matched placebo, once daily, oral
Dietary Supplement: selenase (selenium)
Selenase (Biosyn, Germany) Sodium selenite pentahydrate




Primary Outcome Measures :
  1. urine NTX (N-terminal cross-linking telopeptide of type I collagen) [ Time Frame: 6 months ]
    bone resorption marker


Secondary Outcome Measures :
  1. serum selenium and selenoprotein P [ Time Frame: 6 months ]
    measures of selnium status

  2. other biochemical markers of bone turnover [ Time Frame: 6 months ]
    CTX (C-terminal cross-linking telopeptide of type I collagen), osteocalcin, PINP (Procollagen type I N propeptide)

  3. bone mineral density [ Time Frame: 6m ]
    DXA lumbar spine and total hip

  4. physical function [ Time Frame: 6m ]
    short physical performance battery and hand grip strength

  5. anti-oxidant activity [ Time Frame: 6m ]
    glutathione peroxidase, hydroperoxide, reactive oxygen species

  6. inflammatory markers [ Time Frame: 6m ]
    serum interleukin-6, highly senetive c-reative protein

  7. serum insulin and glucose ratio [ Time Frame: 3m, 6m ]
    safety monitoring for diabetes

  8. thyroid stimulating hormone [ Time Frame: 3m, 6m ]
    safety monitoring for thyroid dysfunction



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

women age over 55y at least 5y postemenopausal willing and able to give informed consent lumbar spine or total hip BMD T-score between -1.0 and -3.0 not clinically requiring treatment for osteoporosis

Exclusion Criteria:

diabetes mellitus, thyroid dysfunction, any conditions known to affect bone metabolism (such as inflammatory disease, parathyroid disease, malabsorption ), medications known to affect bone metabolism (such as osteoporosis treatment, aromatase inhibitors, anti-epileptics), alcohol intake >21 units per week, prolonged immobility (>3 months), fracture in the last year, taken selenium supplements in the last year


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): NCT02832648


Locations
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United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
National Institute for Health Research, United Kingdom
University of Sheffield
Investigators
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Principal Investigator: Jennifer Walsh, MbChB PhD University of Sheffield

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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02832648     History of Changes
Other Study ID Numbers: STH19102
NIHR EME 14-200-20 ( Other Grant/Funding Number: NIHR )
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances