"Vitamin D supplementation and bone health in adults with diabetic nephropathy: the protocol for a randomized controlled trial"

Diana R Mager, Stephanie T Jackson, Michelle R Hoffmann, Kailash Jindal, Peter A Senior, Diana R Mager, Stephanie T Jackson, Michelle R Hoffmann, Kailash Jindal, Peter A Senior

Abstract

Background: Suboptimal vitamin D status is highly prevalent in Northern communities, particularly in those patients with chronic diseases such as diabetes and chronic renal disease. Emerging literature suggests that adherence to daily vitamin D supplementation may be an important factor influencing vitamin D status and overall bone health, but compliance with therapies for bone health is a major challenge. It is unknown what level of vitamin D supplementation will ameliorate or improve suboptimal vitamin D status in patients with diabetic nephropathy or contribute to improved bone health, particularly for those living in northern climates.

Methods/design: The study purpose was to examine two different strategies of vitamin D3 supplementation; daily dosing of 2000 IU per day verses monthly dosing of 40,000 IU per month on markers of vitamin D status, bone health and to examine whether adherence, quality of life and patient satisfaction with the supplementation strategy differs between the two vitamin D strategies in adults diagnosed with diabetic nephropathy.

Discussion: The need for RCTs assessing higher doses of vitamin D3 supplementation at varying frequencies of administration and its impact on bone health in adults with diabetes and chronic kidney disease are needed.

Trial registration: ClinicalTrials.gov NCT01476501.

Figures

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Figure 1
Study design1. 1Abbreviations: Northern Alberta Renal Program (NARP); Alberta Health Services (AHS); randomized controlled trial (RCT); micrograms (mcg); Body mass index (BMI); Dual X-ray absorptiometry (DXA); Bone mineral density (BMD); Hemoglobin A1c (HbA1c); random blood glucose (RBG); estimated glomerular filtration rate (eGFR); 25-hydroxy vitamin D (25(OH)D); 1,25-dihydroxy vitamin D (1,25(OH)2D); alkaline phosphatase (ALP); osteocalcin (OC); bone-specific alkaline phosphatase (BAP); N-telopeptide of type 1 collagen (NTx); fibroblast growth factor-23 (FGF-23).

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