An Intervention to Examine the Effect of Vitamin D on Urine Protein Levels in Type 2 Diabetes
IDEAL-2
Intervention Using Vitamin D for Elevated Urinary ALbumin in Diabetes (IDEAL-2)
2 other identifiers
interventional
320
1 country
1
Brief Summary
Diabetic kidney disease (nephropathy) develops in nearly 40% of patients with type 2 diabetes mellitus. Diabetic nephropathy is caused by damage to the small blood vessels in the kidneys due to uncontrolled blood sugar levels, which mean that the kidneys become less effective at filtering urine. This is associated with albuminuria (protein in the urine). Treatment with some drugs reduces the loss of albumin through the urine and delays disease progression. There is increasing evidence that vitamin D could also be important in management of diabetic kidney disease. The aim of this study is to investigate the efficacy and safety of a combined regimen of calcitriol (active vitamin D) and established drugs for diabetic kidney disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2017
CompletedFirst Submitted
Initial submission to the registry
June 19, 2017
CompletedFirst Posted
Study publicly available on registry
July 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2019
CompletedSeptember 6, 2018
July 1, 2018
2 years
June 19, 2017
September 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Urinary albumin creatinine ratio (ACR) measured biochemically
Urine albumin and creatinine will be measured biochemically and their ratio calculated
26 weeks
Secondary Outcomes (3)
24-hour urine albumin (24h UA) excretion
26 weeks
Estimated glomerular filtration rate (eGFR)
26 weeks
Blood pressure
26 weeks
Other Outcomes (1)
Patient Reported Outcome: Quality of life
26 weeks
Study Arms (2)
Intervention Group
EXPERIMENTALParticipants are treated with angiotensin converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB) AND active vitamin D (Calcitriol) 0.25 micrograms orally per day for 26 weeks.
Usual Care
NO INTERVENTIONParticipants are treated with ACEI/ARB alone for 26 weeks.
Interventions
Active vitamin D (Calcitriol) 0.25 micrograms
Eligibility Criteria
You may qualify if:
- Age greater than or equal to 18 years and less than 80 years
- Diagnosis of T2DM requiring treatment with at least one oral hypoglycaemic medication or insulin 2.1. Subjects will be considered to have established T2DM if the diagnosis of diabetes has been made and the subjects were treated with insulin or an oral hypoglycaemic agent for at least 6 months after diagnosis 2.2. Subjects will be considered to have newly established T2DM if the diagnosis of diabetes was diagnosed with a fasting plasma glucose ≥ 7 mmol/L (126 mg/dL) or haemoglobin A1c is \>6.5% in the past 6 months
- Documented albuminuria defined as a presence of albuminuria on two occasions in the last six months:
- Albumin ≥ 30 mg/24 hour in a 24 hour urine collection, or 3.2. Albumin ≥ 20 μg/min in a short-time urine collection, or 3.3. Albumin ≥ 30 mg/L in a spot urine sample, or 3.4. A spot-urine albumin-creatinine ration (ACR) ≥ 30 mg/g creatinine (≥ 2.5 mg/mmol creatinine in men, ≥ 3.5 mg/mmol creatinine in women)
- Estimated glomerular filtration rate (eGFR) using the 4-variable Modification of Diet in Renal Disease (MDRD) equation of ≥ 25 mL/min/1.73 m2
You may not qualify if:
- If female, positive pregnancy test or planning pregnancy in the subsequent 12 months
- Pregnant
- Breastfeeding
- Corrected serum calcium ≥ 2.62 mmol/L
- Serum Potassium \> 5.2 mmol/L if not on ACEI or ARB; Serum Potassium \> 6.0 mmol/L if on ACEI or ARB
- hydroxyvitamin D (25-OH Vit D) \> 80 ng/mL
- PTH \> 200 pg/mL
- Poorly controlled hypertension defined as systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg
- Systolic blood pressure (SBP) ≤ 110 mm Hg
- History of kidney stones
- History of severe chronic disease (e.g. chronic liver disease)
- Active malignancy
- Recent diagnosis of acute renal failure within 3 months of screening visit
- Likelihood of renal replacement therapy within 1 year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hamad Medical Corporationlead
- Weill Cornell Medical College in Qatarcollaborator
Study Sites (1)
Hamad Medical Corporation
Doha, Qatar
Related Publications (1)
Taheri S, Asim M, Al Malki H, Fituri O, Suthanthiran M, August P; IDEAL-2 Study Team. Intervention using vitamin D for elevated urinary albumin in type 2 diabetes mellitus (IDEAL-2 Study): study protocol for a randomised controlled trial. Trials. 2018 Apr 17;19(1):230. doi: 10.1186/s13063-018-2616-5.
PMID: 29665833DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muhammad Asim, MB BS
Hamad Medical Corporation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2017
First Posted
July 13, 2017
Study Start
May 10, 2017
Primary Completion
May 10, 2019
Study Completion
May 10, 2019
Last Updated
September 6, 2018
Record last verified: 2018-07