Intervention using vitamin D for elevated urinary albumin in type 2 diabetes mellitus (IDEAL-2 Study): study protocol for a randomised controlled trial

Taheri, Shahrad; Asim, Muhammad; Malki, Hassan Al; Fituri, Omar; Suthanthiran, Manikkam; August, Phyllis

doi:10.1186/s13063-018-2616-5

Cited by 8 publications

(5 citation statements)

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“…Findings from human observational studies confirm that vitamin D deficiency is associated with both renal impairment and progression of DKD ( 46 , 47 ). This incontrovertible relationship has led to the initiation of more recent protocols for randomized-control trials, such as evaluating the effect of adding calcitriol to RAAS-blockade therapy on urinary albumin excretion in patients with T2DM ( 48 ). The authors’ proposed study is based on the hypothesis that an active vitamin D analog works synergistically with angiotensin-converting enzyme inhibitors (ACEI) or angiotensin-receptor blockers (ARB) to reduce albuminuria in DKD.…”

Section: Discussionmentioning

confidence: 99%

Vitamin D Analogs Can Retard the Onset or Progression of Diabetic Kidney Disease: A Systematic Review

Uwaezuoke

2021

Front. Clin. Diabetes Healthc.

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IntroductionPrevious studies have shown that vitamin D analogs (such as paricalcitol) can reduce albuminuria in patients with diabetes mellitus and retard the progression of diabetic kidney disease (DKD). A recent systematic review reported significant improvement of renal function in patients with DKD who received vitamin D or its analogs. Study-driven data about their use in improving DKD outcomes have continued to accumulate over the years.AimThis paper aims to systematically review the contemporary evidence about the effectiveness of vitamin D analogs in retarding the onset or progression of DKD.MethodsWith appropriate descriptors, two electronic databases (PubMed and Google Scholar) were searched for articles published between 2015 and 2021 in the English language. Primary studies that fulfilled the inclusion criteria were selected; their titles and abstracts were screened, and duplicates were removed. Relevant data were retrieved from the final selected studies using a preconceived data-extraction form.ResultsA total of eight studies (three randomized-controlled trials, one prospective study, and four cross-sectional studies) were reviewed. A total of 6,243 participants were investigated in the eight studies and comprised young adults, middle-aged adults, and the elderly with a male-gender predominance. One randomized controlled trial reported that paricalcitol significantly improved renal function in type 1 diabetes patients with renal impairment when combined with renin-angiotensin-aldosterone system (RAAS) blockers. A strong correlation between vitamin D deficiency and DKD risk was noted in the majority of the cross-sectional studies. High doses of cholecalciferol (4,000 or 10,000 IU/day), given early in DKD, significantly reduced disease prevalence.ConclusionParicalcitol may retard the onset or progression of DKD, especially if administered in combination with RAAS blockers. The association of vitamin D deficiency with DKD risk also supports this therapeutic effect. Future systematic reviews are still needed to strengthen the current evidence on therapeutic benefit of vitamin D or its analogs in DKD.

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Section: Discussionmentioning

confidence: 99%

Vitamin D Analogs Can Retard the Onset or Progression of Diabetic Kidney Disease: A Systematic Review

Uwaezuoke

2021

Front. Clin. Diabetes Healthc.

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“…[ 21 ] In all these studies, as in the present study, vitamin D seems to reduce proteinuria by inhibiting hyperglycemia-induced podocyte apoptosis, on the one hand, and reducing podocyte damage or reducing podocyte hypertrophy, on the other hand. [ 22 23 ] Other reasons for the decrease in proteinuria include long-term suppression of RAAS and subsequent suppression of renin secretion by vitamin D.[ 9 ]…”

Section: Discussionmentioning

confidence: 99%

“…In a study by Taheri et al . (2018),[ 9 ] it was stated that vitamin D deficiency stimulates renin expression in healthy mice, and injection of 1,25-(OH) 2-D3 reduces renin synthesis. Song et al .…”

Section: Introductionmentioning

confidence: 99%

Anti-proteinuria effect of active vitamin D in patients with type 2 diabetic nephropathy

Khodhal

Aref

Rashidi

et al. 2022

Journal of Family Medicine and Primary Care

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A BSTRACT Introduction: Proteinuria is a common complication in patients with type 2 diabetic nephropathy (DN). The aim of this study was to evaluate the anti-proteinuria effect of active vitamin D in patients with type 2 DN. Methods: A double-blind randomized clinical trial study was conducted on 42 DN patients selected by convenience sampling method. After selecting patients based on inclusion criteria, they were randomly divided into control and intervention groups. Patients in the intervention group received 0.25 mg of active vitamin D per day for 12 weeks. The variables evaluated in the patients on the first day of the intervention included fasting blood sugar (FBS), calcium, phosphorus, creatinine, glomerular filtration rate (GFR), systolic and diastolic blood pressure, and proteinuria. These variables were also evaluated at the end of the first, second, and third month of intervention. Data were collected and analyzed in Statistical Package for Social Sciences software version 22. Results: Around 52.5% of the patients participating in this study were male and 47.5% were female. The mean age of the patients was 55.52 ± 6.58 years. The results of repeated measures analysis showed that active vitamin D significantly reduced proteinuria ( P = 0.000) in patients in the intervention group. The changes in FBS ( P = 0.235), calcium ( P = 0.393), phosphorus ( P = 0.694), creatinine ( P = 0.232), GFR ( P = 0.347), systolic blood pressure ( P = 0.615), and diastolic blood pressure ( P = 0.115) were not significant in patients in the intervention group. Conclusion: Prescription of active vitamin D can significantly reduce the incidence of proteinuria in patients with DN.

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“…These conflict results may be mainly due to differences in study population and adjusted covariates. Besides, the evidence for vitamin D supplementation to prevent DKD remains weak due to the discordances in published data [65][66][67][68]. Taken together, the impacts of VDD on DKD need to be further studied in the future.…”

Section: Discussionmentioning

confidence: 99%

Associations between vitamin D status and diabetic complications in Chinese population with type 2 diabetes mellitus: a cross-sectional study

Xiao

Wei

Xiong

et al. 2020

Preprint

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Background Vitamin D status has been linked to diabetes-related complications due to multiple extraskeletal effects. We aimed to investigate the association between vitamin D deficiency (VDD) and diabetic vascular complications, including diabetic retinopathy (DR), diabetic kidney disease (DKD), and diabetic foot ulcers (DFU).Methods A total of 4284 Chinese patients with type 2 diabetic mellitus (T2DM) were enrolled into the cross-sectional study. VDD was defined as serum 25-hydroxyvitamin D < 50 nmol/L. Demographic data, physical measurements, laboratory measurements, comorbidities, and related medications were collected and analyzed by VDD status. Poisson regression with robust variance estimation and binary logistic regression were performed to explore the relationship between VDD and diabetic complications.Results The prevalence of VDD, DR, DKD, DFU accounted to 71.7% (95% confidence intervals [CI]: 70.3%-73.0%), 28.5% (95% CI: 27.2%-29.9%), 28.2% (95% CI: 26.8%-29.5%) and 5.7% (95% CI: 5.1%-6.5%), respectively. The prevalence ratios (95% CI) for DR and DKD by VDD status, adjusted for demographics, physical measurements, laboratory measurements, related complications and comorbidities, and medications, were 1.093 (0.983–1.215) and 1.041 (0.937–1.156), respectively. The odds ratio (95% CI) for DFU by VDD status was 1.656 (1.159–2.367) in the final adjusted model. Meanwhile, the prevalence of VDD was significantly higher in patients with DFU compared with patients without DFU.Conclusions The present study firstly indicated that VDD was significantly associated with a higher prevalence of DFU among Chinese T2DM patients. The association between VDD status and DR or DKD was not significant when adjusting for all potential covariates. Vitamin D screening or supplementation may be beneficial to prevent diabetic complications and improve the prognosis of T2DM patients.

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Intervention using vitamin D for elevated urinary albumin in type 2 diabetes mellitus (IDEAL-2 Study): study protocol for a randomised controlled trial

Cited by 8 publications

References 50 publications

Vitamin D Analogs Can Retard the Onset or Progression of Diabetic Kidney Disease: A Systematic Review

Vitamin D Analogs Can Retard the Onset or Progression of Diabetic Kidney Disease: A Systematic Review

Anti-proteinuria effect of active vitamin D in patients with type 2 diabetic nephropathy

Associations between vitamin D status and diabetic complications in Chinese population with type 2 diabetes mellitus: a cross-sectional study

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