Selenium for Musculoskeletal Health

NCT02832648 | Completed Phase 3 DMC

• 2 other identifiers: STH19102NIHR EME 14-200-20
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• urine NTX (N-terminal cross-linking telopeptide of type I collagen)

  bone resorption marker

  6 months

Secondary Outcomes (8)

• serum selenium and selenoprotein P

  6 months

• other biochemical markers of bone turnover

  6 months

• bone mineral density

  6m

• physical function

  6m

• anti-oxidant activity

  6m

Study Arms (3)

selenase 200mcg

EXPERIMENTAL

selenium as selenase 200mcg once daily, oral

Dietary Supplement: selenase (selenium)

selenase 50mcg

EXPERIMENTAL

selenium as selenase 50mcg once daily, oral

Dietary Supplement: selenase (selenium)

placebo

PLACEBO COMPARATOR

matched placebo, once daily, oral

Dietary Supplement: selenase (selenium)

Interventions

selenase (selenium) DIETARY_SUPPLEMENT

Selenase (Biosyn, Germany) Sodium selenite pentahydrate

placebo; selenase 200mcg; selenase 50mcg

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• University of Sheffield: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

Location

Related Publications (1)

• Walsh JS, Jacques RM, Schomburg L, Hill TR, Mathers JC, Williams GR, Eastell R. Effect of selenium supplementation on musculoskeletal health in older women: a randomised, double-blind, placebo-controlled trial. Lancet Healthy Longev. 2021 Apr;2(4):e212-e221. doi: 10.1016/S2666-7568(21)00051-9.

  PMID: 33842907 DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Selenium

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Officials

• Jennifer Walsh, MbChB PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 14, 2016
• Study Start: January 1, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: January 6, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)