An Intervention to Examine the Effect of Vitamin D on Urine Protein Levels in Type 2 Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03216564
• Date of registration: 19/06/2017
• Prospective Registration: No
• Primary sponsor: Hamad Medical Corporation
• Public title: An Intervention to Examine the Effect of Vitamin D on Urine Protein Levels in Type 2 Diabetes IDEAL-2
• Scientific title: Intervention Using Vitamin D for Elevated Urinary ALbumin in Diabetes (IDEAL-2)
• Date of first enrolment: May 10, 2017
• Target sample size: 320
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03216564
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Qatar

Contacts

• Name: Muhammad Asim, MB BS
• Affiliation: Hamad Medical Corporation

• Name: Muhammad Asim, MB BS

• Name: Shahrad Taheri, MB BS PhD

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age greater than or equal to 18 years and less than 80 years

2. 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

3. Documented albuminuria defined as a presence of albuminuria on two occasions in the
last six months:

3.1. 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)

4. Estimated glomerular filtration rate (eGFR) using the 4-variable Modification of Diet
in Renal Disease (MDRD) equation of = 25 mL/min/1.73 m2

Exclusion Criteria:

1. If female, positive pregnancy test or planning pregnancy in the subsequent 12 months

2. Pregnant

3. Breastfeeding

4. Corrected serum calcium = 2.62 mmol/L

5. Serum Potassium > 5.2 mmol/L if not on ACEI or ARB; Serum Potassium > 6.0 mmol/L if on
ACEI or ARB

6. 25-hydroxyvitamin D (25-OH Vit D) > 80 ng/mL

7. PTH > 200 pg/mL

8. Poorly controlled hypertension defined as systolic blood pressure = 180 mm Hg or
diastolic blood pressure = 110 mm Hg

9. Systolic blood pressure (SBP) = 110 mm Hg

10. History of kidney stones

11. History of severe chronic disease (e.g. chronic liver disease)

12. Active malignancy

13. Recent diagnosis of acute renal failure within 3 months of screening visit

14. Likelihood of renal replacement therapy within 1 year



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetic Nephropathies

Intervention(s)

Drug: Calcitriol

Primary Outcome(s)

Urinary albumin creatinine ratio (ACR) measured biochemically [Time Frame: 26 weeks]

Secondary Outcome(s)

24-hour urine albumin (24h UA) excretion [Time Frame: 26 weeks]

Blood pressure [Time Frame: 26 weeks]

Estimated glomerular filtration rate (eGFR) [Time Frame: 26 weeks]

Secondary ID(s)

1400039

16235/16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Weill Cornell Medical College in Qatar