Evidence map›Paper›PMID 29665833›Full record

ArticleTrials2018

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

Shahrad Taheri, Muhammad Asim, Hassan Al Malki, Omar Fituri, Manikkam Suthanthiran, Phyllis August, IDEAL-2 Study Team

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03216564 (Intervention Using Vitamin D for Elevated Urinary ALbumin in Diabetes), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03216564 phase3unknown statusnot on this map

Intervention Using Vitamin D for Elevated Urinary ALbumin in Diabetes (IDEAL-2)

TypeinterventionalSponsorHamad Medical CorporationRan2017 to 2019Enrolled320ConditionsDiabetic NephropathiesArmsCalcitriol
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

Shahrad TaheriDepartment of Medicine, Weill Cornell Medicine - Qatar, Doha, Qatar. staheri@me.com.ORCID http://orcid.org/0000-0001-8314-1500
Muhammad AsimDepartment of Nephrology, Hamad Medical Corporation, Doha, Qatar.
Hassan Al MalkiDepartment of Nephrology, Hamad Medical Corporation, Doha, Qatar.
Omar FituriDepartment of Nephrology, Hamad Medical Corporation, Doha, Qatar.
Manikkam SuthanthiranJoan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine - New York, New York, USA.
Phyllis AugustJoan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine - New York, New York, USA.
IDEAL-2 Study Team
Cornell University · USHamad Medical Corporation · QAWeill Cornell Medical College in Qatar · QA

Funding

Qatar National Research Fund NPRP 4-1392-3-345
6 · The paper itself

Abstract

backgroundThe 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.

methodsThe 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 registrationISRCTN, ISRCTN86739609 . Registered on 7 June 2017. ClinicalTrials.gov, NCT03216564 . Registered on 13 July 2017.

Indexed as

AdultAgedAlbuminuriaAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsCalcitriolDiabetes Mellitus, Type 2Diabetic NephropathiesDrug Therapy, CombinationFemaleHumansKidneyMaleMiddle AgedQatarRandomized Controlled Trials as TopicAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsCalcitriolVitaminsAlbuminuriaAngiotensin converting enzyme inhibitorAngiotensin receptor blockerDiabetic kidney diseaseType 2 diabetes mellitusVitamin D

Identifiers

PMID29665833
PMCPMC5905112
OpenAlexW2803592588

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.