Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000714886
Ethics application status
Approved
Date submitted
3/07/2012
Date registered
4/07/2012
Date last updated
27/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of vitamin D supplementation on glucose control and inflammatory response in type II diabetic patients.
Scientific title
Effect of vitamin D supplementation on glucose control and inflammatory response in type II diabetic patients.
Secondary ID [1] 280671 0
Nil
Universal Trial Number (UTN)
U1111-1131-8300
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type II Diabetes Mellitus 286692 0
Vitamin D deficiency 286693 0
Condition category
Condition code
Metabolic and Endocrine 286991 286991 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Vitamin D3 (Cholecalciferol) capsules. (5000 IU/day) for 12 weeks.
Intervention code [1] 285077 0
Treatment: Drugs
Comparator / control treatment
Arm 2: Placebo Capsules. (one capsule/day) for 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 287330 0
Changes in A1C level using serum assay.
Timepoint [1] 287330 0
At baseline and week 12
Secondary outcome [1] 297914 0
Changes in Homeostatic Model Assessment (HOMA) of beta cell function and insulin resistance (IR).
Timepoint [1] 297914 0
At baseline and week 12.
Secondary outcome [2] 297915 0
Changes in metabolic syndrome components (blood pressure, waist circumference, body mass index, fasting blood glucose, and lipid profile)
Timepoint [2] 297915 0
At baseline, week 4, and week 12
Secondary outcome [3] 297916 0
Changes in the level of select biomarkers of inflammation (IL-6, TNF-alpha, CRP, adiponectin, and leptin) using serum bioplex assay.
Timepoint [3] 297916 0
At baseline and week 12.
Secondary outcome [4] 297917 0
Changes in 25(OH)D, and parathyroid hormone (PTH) levels using serum assay.
Timepoint [4] 297917 0
At baseline, week 4, and week 12
Secondary outcome [5] 298175 0
Changes in parathyroid hormone related peptide (PTH-rP) using serum ELISA.
Timepoint [5] 298175 0
At baseline and week 12.

Eligibility
Key inclusion criteria
* Adult (aged 21-75 year-old) at start of screening.

* Type II Diabetic patients.

* A1C level (> or =) 6 within the last 3 months.

* Insulin Resistance based on Homeostatic model assessment (HOMA-IR) (> or =) 2

* Serum 25-hydroxyvitamin D level (25(OH)D) level < (20 ng/ml) (50 nmol/l)

* Normal kidney function (eGFR > 90) using CKD-EPI formula

* On a stable oral hypoglycemic drug regimen for at least 30 days prior to screening. Those who are on thiazolidinedione should be on stable regimen for at least 6 months prior to screening.

* On stable regimen of lipid lowering drug for at least 30 days prior to screening or not on one at all.

* On stable regimen of antihypertensive drugs for at least 30 days prior to screening or not on one at all.
Minimum age
21 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1)History of any of the following diseases:
A) Chronic kidney diseases eGFR < 90
B) Chronic liver disease.
C) Congestive heart failure.
D) Myocardial infarction (MI) within the last 6 months.
E) History of cerebrovascular accident.
F) Hypercalcemia (serum calcium > 10.2 mg/dl)
G) Proteinurea (> 3.5 g/24 hours)
H) Autoimmune or inflammatory diseases [(e.g.
sarcoidosis, systemic lupus erythematous (SLE),
rheumatoid arthritis (RA)].
I) Gastrointestinal malabsorption disorders (e.g.
celiac, crohn’s disease)
J) Primary parathyroid disorders.
K) malignancy
2) Currently taking any of the following drugs:
A) Insulin.
B) Activated Vitamin D analogs or nutritional vitamin
D agents > 800 IU/day
C) Glucocorticoid
D) Antiepeleptic (e.g. phenytoin, phosphenytoin,
barbiturate, primidone)
E) Carbamezapine
F) Digoxin
G) Cholestyramine
H) Orlistat
3) History of gastric bypass surgery or removal of part of stomach or small intestine.
4) Pregnant or breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment outside Australia
Country [1] 4362 0
Saudi Arabia
State/province [1] 4362 0

Funding & Sponsors
Funding source category [1] 285437 0
University
Name [1] 285437 0
Albany College of Pharmacy And Health Sciences
Country [1] 285437 0
United States of America
Primary sponsor type
University
Name
Albany College of Pharmacy and Health Sciences (ACPHS)
Address
Albany College of Pharmacy and Health Sciences (ACPHS)
O'Brien Building, suite 231
106 New Scotland Avenue
Albany, N.Y.12208
Country
United States of America
Secondary sponsor category [1] 284288 0
Individual
Name [1] 284288 0
Mohammed Al-Sofiani
Address [1] 284288 0
Albany College of Pharmacy and Health Sciences (ACPHS)
O'Brien Building, suite 231
106 New Scotland Avenue
Albany, N.Y.12208
Country [1] 284288 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287446 0
Institutional Review Board- King Saud University- College of Medicine
Ethics committee address [1] 287446 0
Ethics committee country [1] 287446 0
Saudi Arabia
Date submitted for ethics approval [1] 287446 0
Approval date [1] 287446 0
31/10/2011
Ethics approval number [1] 287446 0
Ethics committee name [2] 287566 0
Institution Review Board of Albany College of Pharmacy
Ethics committee address [2] 287566 0
Ethics committee country [2] 287566 0
United States of America
Date submitted for ethics approval [2] 287566 0
Approval date [2] 287566 0
01/03/2012
Ethics approval number [2] 287566 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34310 0
Address 34310 0
Country 34310 0
Phone 34310 0
Fax 34310 0
Email 34310 0
Contact person for public queries
Name 17557 0
MOHAMMED AL-SOFIANI, MD
Address 17557 0
Albany College of Pharmacy and Health Sciences (ACPHS)
O'Brien Building, suite 231
106 New Scotland Avenue
Albany, N.Y.12208
Country 17557 0
United States of America
Phone 17557 0
+1 518 253-9929
Fax 17557 0
Email 17557 0
[email protected]
Contact person for scientific queries
Name 8485 0
Darius L. Mason. Pharm.D., BCPS
Address 8485 0
Albany College of Pharmacy and Health Sciences (ACPHS)
106 New Scotland Ave.
Albany, NY 12208
Country 8485 0
United States of America
Phone 8485 0
+1 518 694-7449
Fax 8485 0
Email 8485 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIEffect of Vitamin D Supplementation on Glucose Control and Inflammatory Response in Type II Diabetes: A Double Blind, Randomized Clinical Trial2015https://doi.org/10.5812/ijem.22604
N.B. These documents automatically identified may not have been verified by the study sponsor.