Optimising Vitamin D Status in Older People (VDOP)

Phase 1

• Conditions: Bone mineral density in older people; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2011-004890-10-GB
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-10
• Study Completion: 2014-06-05
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 379

Inclusion Criteria

1. Ambulant, community dwelling men and women aged 70 years and above 2. Individuals capable of giving informed consent on their own behalf 3. Individuals willing to attend the Study Centre (CARU) on six occasions and to be contacted by telephone at monthly intervals between study visits over twelve months The inclusion criteria are mainly restricted to age and ability to participate in the study. The age cut-off used is the same as the threshold for older age used in the most recently published review and recommendations
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 375

Exclusion Criteria

1. Current antiresorptive or anabolic treatment for osteoporosis 2. Treatment with bisphosphonates for osteoporosis in past two years 3. Current use of vitamin D (>400 IU/day) or calcium (>500 mg/day) (including use of over-the-counter preparations) 4. Fragility fracture in the previous six months 5. Known primary hyperparathyroisism 6. Hypercalcaemia (albumin-adjusted plasma calcium > 2.60 mmol/l) 7. Renal impairment (Stage 4-5 Chronic Kidney Disease: GFR < 30 ml/min/1.73m2) 8. History of renal stones 9. Peanut allergy The exclusion criteria include the presence of a health condition or treatment which is likely to independently affect the outcome measures (criteria: 1, 2, 3, 4, 5, 8) or increase the risk of developing adverse effects with vitamin D supplementation (criteria: 6, 9).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified