Rationale for Raising Current Clinical Practice Guideline Target for Serum 25-Hydroxyvitamin D in Chronic Kidney Disease
Strugnell SA, Sprague SM, Ashfaq A, Petkovich M, Bishop CW
American journal of nephrology · 56 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Funding not disclosed
Publication
- Published
- 2019-01-01 · Am J Nephrol · vol. 49 · issue 4 · pp. 284–293
- Publisher
- Karger Publishers
- Cited
- 74 citations · more than 97% of similar papers · 5.3× the field average
- Impact
- Top 10% most cited in its field
- References
- 42 works
- Access
- Paywalled
- Research areas
- Parathyroid Disorders and Treatments · Vitamin D Research Studies · Thyroid Disorders and Treatments
- Keywords
- Secondary hyperparathyroidism, Medicine, Vitamin D and neurology, Internal medicine, Kidney disease, Endocrinology, Renal function, Parathyroid hormone, Paricalcitol, Calcifediol, Hyperparathyroidism, Creatinine, Fibroblast growth factor 23, Placebo, Urology, vitamin D deficiency, Calcium, Pathology
- MeSH
- humans, vitamin d deficiency, hyperparathyroidism, secondary, calcifediol, parathyroid hormone, vitamin d, drug monitoring, double-blind method, reference values, aged, middle aged, female, male, renal insufficiency, chronic, practice guidelines as topic, fibroblast growth factor-23
5 authors
From US, CA
- Stephen A. StrugnellOPKO Health (United States)
- Stuart Michael SpragueEndeavor Health
- Akhtar AshfaqOPKO Health (United States)
- Martin P. PetkovichQueen's University
- Charles W. BishopOPKO Health (United States)
Abstract
Background
Vitamin D repletion is recommended for secondary hyperparathyroidism (SHPT) and associated vitamin D insufficiency (VDI) in chronic kidney disease (CKD), but optimal levels of serum total 25-hydroxyvitamin D remain undefined. Clinical practice guidelines target sufficiency, whereas recent data indicate that higher levels are required to control the elevation of intact parathyroid hormone (iPTH) as CKD advances. This secondary analysis of 2 randomized controlled trials seeks to identify the minimum level of mean serum 25-hydroxyvitamin D required to control SHPT arising from VDI in stage 3 or 4 CKD.
Methods
Adult subjects (n = 429) with SHPT, VDI, and stage 3 or 4 CKD were stratified by stage and treated daily with either extended-release calcifediol (ERC) or placebo in 2 identical, parallel, randomized, double-blind studies. After treatment for 26 weeks, all subjects were ranked by the level of serum total 25-hydroxyvitamin D and divided into quintiles in order to examine the relationships between the degree of vitamin D repletion and the associated changes in plasma iPTH, serum bone turnover markers, calcium, phosphorus, intact fibroblast growth factor 23 (FGF23) and vitamin D metabolites, estimated glomerular filtration rate (eGFR), and urine calcium:creatinine (Ca:Cr) ratio.
Results
Progressive increases in serum 1,25-dihydroxyvitamin D and reductions in plasma iPTH and serum bone turnover markers were observed as mean posttreatment serum 25-hydroxyvitamin D rose from 13.9 ng/mL (in Quintile 1) to 92.5 ng/mL (in Quintile 5), irrespective of CKD stage. Mean serum calcium, phosphorus and FGF23, eGFR, and urine Ca:Cr ratio (collectively "safety parameters") did not significantly change from Quintile 1. Suppression of iPTH and bone turnover markers was not observed until serum 25-hydroxyvitamin D rose to at least 50.8 ng/mL (Quintile 3).
Conclusion
ERC therapy produced exposure-dependent reductions in plasma iPTH and bone turnover markers only when mean serum total 25-hydroxyvitamin D reached at least 50.8 ng/mL, indicating that current targets for vitamin D repletion therapy in CKD are too low. Gradual elevation of mean serum 25-hydroxyvitamin D to 92.5 ng/mL was not associated with significant adverse changes in safety parameters.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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