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
Inez Schoenmakers,
Roger M Francis,
Elaine McColl,
Thomas Chadwick,
Gail R Goldberg,
Christine Harle,
Alison Yarnall,
Jennifer Wilkinson,
Jennie Parker,
Ann Prentice,
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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.
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Comments by VitaminDWiki
- They appear to be using enough vitamin D to be successful
- Their goal of increasing Bone Mineral Density would have been better achieved if they had also included cofactors proven to be needed to build bone – such as Magnesium and Vitamin K2
- Expect that about 3% of the participants have side effects due to not balancing the cofactors.
- Would have been better if study had used an initial loading dose ( say 200,000 IU), since the beneifts from the dosing in this trial will not become apparent for about 6 months.
- Hope the study was able to find enough seniors who are taking < 401 IU of vitamin D daily to be subjects in this trail.
- Expect that the participants knew which was getting the high level of vitamin D in about 6 months – as they will be feeling much better, have less pain, etc.
Personal Disclosure by Henry Lahore, admin of VitaminDWiki
I am almost 70 years old
I take 7X as much vitamin D in the winter as was used by this RCT (50,000 IU every 4 days)
I also have balanced all of the cofactors (CA 500, Mg 500 etc)
Am far healthier and alert than when I was 30 years younger.
See also VitaminDWiki
- Overview Seniors and Vitamin D
- Antibiotic use cut in half by elderly (over 70) after monthly 60,000 IU of vitamin D – RCT Dec 2013 the above study was not recording antibiotic use
- 80 percent of the characteristics of frailty associated with low vitamin D – May 2013 the above study was not measuing fraility
- 1600 IU vitamin D was enough to get all (white, non-obese) elderly to 20 ng – RCT Dec 2012 1600 x 30 days = 48,000 IU
So we can estimate that the elderly will all get > 20 ng, which is not very much - 600,000 IU vitamin D normalized virtually all seniors in 3 months (Injection better than oral)– May 2012
- Overview Fractures and Falls and Vitamin D at least 60,000 IU of vitamin D (and some Calcium) needed to significantly reduce falling
- 20 percent fewer male hip fractures if more Magnesium in the water – July 2013
- Vitamin K-2 (180 ug MK-7) helped both bone density and strength – RCT March 2013
- Summary of Vitamin D trials - Grant Nov 2012