Vitamin D in older people

Not Applicable

Completed

• Conditions: Musculoskeletal diseases; Musculoskeletal Diseases; Vitamin D deficiency, unspecified

• Registration Number: ISRCTN35648481
• Lead Sponsor: ewcastle Joint Research Office

Brief Summary

1. 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24041337 2. 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/30624670 [added 10/01/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-16
• Study Completion: 2014-06-06
• Last Update Posted: 16 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 379

Inclusion Criteria

Inclusion criteria as of 07/04/2017:
1. Ambulant, community dwelling men and women aged 70 years and above (by end April2013)
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

Original 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
4. Male and female participants
5. > 70 years old

Exclusion Criteria

Exclusion criteria as of 07/04/2017:
1. Current antiresorptive or anabolic treatment for osteoporosis
2. Treatment with bisphosphonates for osteoporosis in past two years
3. Current supplement 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 hyperparathyroidism
6. Hypercalcaemia (albumin-adjusted plasma calcium > 2.60 mmol/l)
7. Renal impairment (Stage 4-5 Chronic Kidney Disease: eGFR < 30 ml/min/1.73m2)
8. History of renal stones

Original 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified