Vitamin D supplementation in older people (VDOP): Study protocol for a randomised controlled intervention trial with monthly oral dosing with 12,000 IU, 24,000 IU or 48,000 IU of vitamin D₃.
Study Goal
The researchers aimed to determine the optimal dosage and plasma concentration of vitamin D for maintaining bone health in older people, assessing its effects on bone mineral density, biochemical markers, and safety.
Results Summary
The abstract does not provide specific results regarding Calcium's effects, as the study focuses on vitamin D supplementation and its impact on bone health markers.
Population
Older community-dwelling men and women (≥70 years) in Northern England.
Effective Dosage
12,000 IU, 24,000 IU, or 48,000 IU of vitamin D3 orally each month.
Duration
One year.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
three oral dosages of vitamin D given for one year | neutral | bone mineral density (BMD) and biochemical markers of vitamin D metabolism, bone turnover and safety | older people | - | test the effect | #1 |
Vitamin D supplementation | decrease | bone loss, falls and fractures | - | - | yielded conflicting results with regard to decreasing rates | #2 |
12,000 international units (IU), 24,000 IU or 48,000 IU of vitamin D3 orally each month for one year | neutral | BMD, plasma 25OHD, PTH and biochemical markers of bone turnover and safety, quality of life and physical performance | Older (≥70 years) community dwelling men and women | - | to assess | #3 |
vitamin D supplementation | neutral | bone health | - | - | required to maintain | #4 |
vitamin D supplementation | neutral | effect of vitamin D on bone | - | - | to develop a set of biochemical markers that reflects the effect | #5 |
vitamin D supplementation | neutral | fracture risk | - | - | to aid future studies investigating the effect | #6 |
UNLABELLED: The randomised, double blind intervention trial 'Optimising Vitamin D Status in Older People' (VDOP) will test the effect of three oral dosages of vitamin D given for one year on bone mineral density (BMD) and biochemical markers of vitamin D metabolism, bone turnover and safety in older people. VDOP is funded by Arthritis Research UK, supported through Newcastle University and MRC Human Nutrition Research and sponsored by the Newcastle upon Tyne Hospitals NHS Foundation Trust.a BACKGROUND: Vitamin D insufficiency is common in older people and may lead to secondary hyperparathyroidism, bone loss, impairment of muscle function and increased risk of falls and fractures. Vitamin D supplementation trials have yielded conflicting results with regard to decreasing rates of bone loss, falls and fractures and the optimal plasma concentration of 25 hydroxy vitamin D (25OHD) for skeletal health remains unclear. METHOD/DESIGN: Older (≥70 years) community dwelling men and women are recruited through General Practices in Northern England and 375 participants are randomised to take 12,000 international units (IU), 24,000 IU or 48,000 IU of vitamin D3 orally each month for one year starting in the winter or early spring. Hip BMD and anthropometry are measured at baseline and 12 months. Fasting blood samples are collected at baseline and three-month intervals for the measurement of plasma 25OHD, parathyroid hormone (PTH), biochemical markers of bone turnover and biochemistry to assess the dose-response and safety of supplementation. Questionnaire data include falls, fractures, quality of life, adverse events and outcomes, compliance, dietary calcium intake and sunshine exposure. DISCUSSION: This is the first integrated vitamin D supplementation trial in older men and women using a range of doses given at monthly intervals to assess BMD, plasma 25OHD, PTH and biochemical markers of bone turnover and safety, quality of life and physical performance. We aim to investigate the vitamin D supplementation and plasma 25OHD concentration required to maintain bone health and to develop a set of biochemical markers that reflects the effect of vitamin D on bone. This will aid future studies investigating the effect of vitamin D supplementation on fracture risk.#ISRCTN 35648481 (assigned 16 August 2012), EudraCT 2011-004890-10.