PMID- 29665833 OWN - NLM STAT- MEDLINE DCOM- 20190314 LR - 20240314 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 19 IP - 1 DP - 2018 Apr 17 TI - Intervention using vitamin D for elevated urinary albumin in type 2 diabetes mellitus (IDEAL-2 Study): study protocol for a randomised controlled trial. PG - 230 LID - 10.1186/s13063-018-2616-5 [doi] LID - 230 AB - BACKGROUND: The prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide. T2DM is associated with serious macro- and microvascular complications. In particular, diabetic kidney disease (DKD), which begins with excessive urinary albumin excretion, has a significant impact on affected individuals and is costly to healthcare services. Inhibition of the renin-angiotensin-aldosterone system (RAAS) with angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) significantly reduces albuminuria in diabetes, but this effect is not observed in all those treated. Active vitamin D analogues have been observed to be reno-protective through inhibition of RAAS in animal and human studies. Therefore, it can be hypothesised that an active vitamin D analogue will have an additional benefit to ACEI/ARB treatment for albuminuria reduction in DKD. METHODS: The planned study is an ongoing non-blinded randomised controlled parallel-group trial examining the impact, in individuals with T2DM, of the addition of bioactive vitamin D (calcitriol) to RAAS inhibition treatment using ACI or ARB on urinary albumin excretion over a period of 26 weeks. The primary outcome measure is the urinary albumin creatinine ratio. It is planned for the study to recruit 320 participants. Other outcome measures of interest include 24-h urine albumin (24 h UA) excretion, estimated glomerular filtration rate (eGFR), blood pressure and quality of life. Safety will be assessed throughout. DISCUSSION: If the addition of calcitriol to RAAS inhibition with ACEI or ARB safely results in a significant reduction in albuminuria, the study adds to the body of evidence supporting a role for vitamin D in reno-protection, will inform clinical practice and could result in significant reduction of healthcare costs associated with DKD. TRIAL REGISTRATION: ISRCTN, ISRCTN86739609 . Registered on 7 June 2017. ClinicalTrials.gov, NCT03216564 . Registered on 13 July 2017. FAU - Taheri, Shahrad AU - Taheri S AUID- ORCID: 0000-0001-8314-1500 AD - Department of Medicine, Weill Cornell Medicine - Qatar, Doha, Qatar. staheri@me.com. AD - Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine - New York, New York, USA. staheri@me.com. AD - Clinical Research Core, Weill Cornell Medicine - Qatar, Doha, Qatar. staheri@me.com. AD - Department of Medicine, Hamad Medical Corporation, Qatar Metabolic Institute (QMI), Doha, Qatar. staheri@me.com. FAU - Asim, Muhammad AU - Asim M AD - Department of Nephrology, Hamad Medical Corporation, Doha, Qatar. FAU - Al Malki, Hassan AU - Al Malki H AD - Department of Nephrology, Hamad Medical Corporation, Doha, Qatar. FAU - Fituri, Omar AU - Fituri O AD - Department of Nephrology, Hamad Medical Corporation, Doha, Qatar. FAU - Suthanthiran, Manikkam AU - Suthanthiran M AD - Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine - New York, New York, USA. FAU - August, Phyllis AU - August P AD - Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine - New York, New York, USA. CN - IDEAL-2 Study Team LA - eng SI - ClinicalTrials.gov/NCT03216564 GR - NPRP 4-1392-3-345/Qatar National Research Fund/ GR - NPRP 4-1392-3-345/Qatar National Research Fund/ GR - NPRP 4-1392-3-345/Qatar National Research Fund/ PT - Clinical Trial Protocol PT - Journal Article DEP - 20180417 PL - England TA - Trials JT - Trials JID - 101263253 RN - 0 (Angiotensin Receptor Antagonists) RN - 0 (Angiotensin-Converting Enzyme Inhibitors) RN - 0 (Vitamins) RN - FXC9231JVH (Calcitriol) SB - IM MH - Adult MH - Aged MH - Albuminuria/*drug therapy/etiology/physiopathology/urine MH - Angiotensin Receptor Antagonists/therapeutic use MH - Angiotensin-Converting Enzyme Inhibitors/therapeutic use MH - Calcitriol/adverse effects/*therapeutic use MH - Diabetes Mellitus, Type 2/*complications MH - Diabetic Nephropathies/*drug therapy/etiology/physiopathology/urine MH - Drug Therapy, Combination MH - Female MH - Humans MH - Kidney/*drug effects/physiopathology MH - Male MH - Middle Aged MH - Qatar MH - Randomized Controlled Trials as Topic MH - Time Factors MH - Treatment Outcome MH - Vitamins/adverse effects/*therapeutic use PMC - PMC5905112 OTO - NOTNLM OT - Albuminuria OT - Angiotensin converting enzyme inhibitor OT - Angiotensin receptor blocker OT - Diabetic kidney disease OT - Type 2 diabetes mellitus OT - Vitamin D COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: Ethical approval for the study has been obtained from the Hamad Medical Corporation IRB (no. 16235/16), Weill Cornell Medicine - Qatar IRB (14-00039). All participants provide written informed consent. COMPETING INTERESTS: The authors declare that they have no competing interests. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. FIR - Asim, Muhammad IR - Asim M FIR - Al-Malki, Hassan IR - Al-Malki H FIR - Fituri, Omar IR - Fituri O FIR - Rachid, Awad IR - Rachid A FIR - Adel, Abdelaziz IR - Adel A FIR - Hamdi, Ahmed IR - Hamdi A FIR - Nauman, Awais IR - Nauman A FIR - Farghaly, Gamal IR - Farghaly G FIR - Elkadi, Mohamad IR - Elkadi M FIR - Taheri, Shahrad IR - Taheri S FIR - August, Phyllis IR - August P FIR - Suthanthiran, Manikkam IR - Suthanthiran M FIR - Jayyousi, Amin IR - Jayyousi A FIR - Ibrahim, Buthaina IR - Ibrahim B FIR - Janahi, Ibrahim IR - Janahi I FIR - Menzies, Robert IR - Menzies R FIR - Farook, Seleena IR - Farook S FIR - Bashir, Salma IR - Bashir S FIR - Chagoury, Odette IR - Chagoury O FIR - Choudhury, Sopna IR - Choudhury S FIR - Payra, Sherryl IR - Payra S FIR - Omar, Omar IR - Omar O FIR - Pallayova, Maria IR - Pallayova M FIR - Agouba, Sahar IR - Agouba S FIR - Elgazzar, Sally IR - Elgazzar S FIR - Elshakh, Hadya IR - Elshakh H FIR - Gad, Hoda IR - Gad H FIR - Chalil, Samah IR - Chalil S FIR - Dahir, Amany IR - Dahir A FIR - Tohid, Hiba IR - Tohid H FIR - Chinnaiyan, Subitha IR - Chinnaiyan S EDAT- 2018/04/19 06:00 MHDA- 2019/03/15 06:00 PMCR- 2018/04/17 CRDT- 2018/04/19 06:00 PHST- 2017/12/19 00:00 [received] PHST- 2018/03/28 00:00 [accepted] PHST- 2018/04/19 06:00 [entrez] PHST- 2018/04/19 06:00 [pubmed] PHST- 2019/03/15 06:00 [medline] PHST- 2018/04/17 00:00 [pmc-release] AID - 10.1186/s13063-018-2616-5 [pii] AID - 2616 [pii] AID - 10.1186/s13063-018-2616-5 [doi] PST - epublish SO - Trials. 2018 Apr 17;19(1):230. doi: 10.1186/s13063-018-2616-5.