Effect of vitamin D supplementation on glucose control and inflammatory response in type II diabetic patients.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12612000714886
• Date of registration: 04/07/2012
• Prospective Registration: No
• Primary sponsor: Albany College of Pharmacy and Health Sciences (ACPHS)
• 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.
• Date of first enrolment: 28/11/2011
• Target sample size: 22
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12612000714886.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;

Countries of recruitment

Saudi Arabia

Contacts

• Name: Darius L. Mason. Pharm.D., BCPS

• Name: MOHAMMED AL-SOFIANI, MD

Key inclusion & exclusion criteria

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.
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.

Age minimum: 21 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Metabolic and Endocrine - Diabetes

Type II Diabetes Mellitus;Vitamin D deficiency;
Type II Diabetes Mellitus
Vitamin D deficiency

Intervention(s)

Arm 1: Vitamin D3 (Cholecalciferol) capsules. (5000 IU/day) for 12 weeks.

Primary Outcome(s)

Changes in A1C level using serum assay.[At baseline and week 12]

Secondary Outcome(s)

Changes in the level of select biomarkers of inflammation (IL-6, TNF-alpha, CRP, adiponectin, and leptin) using serum bioplex assay.[At baseline and week 12.]

Changes in Homeostatic Model Assessment (HOMA) of beta cell function and insulin resistance (IR).[At baseline and week 12.]

Changes in 25(OH)D, and parathyroid hormone (PTH) levels using serum assay.[At baseline, week 4, and week 12]

Changes in parathyroid hormone related peptide (PTH-rP) using serum ELISA.[At baseline and week 12.]

Changes in metabolic syndrome components (blood pressure, waist circumference, body mass index, fasting blood glucose, and lipid profile)[At baseline, week 4, and week 12]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Albany College of Pharmacy And Health Sciences

Secondary Sponsor(s)

Mohammed Al-Sofiani

Ethics review

Status: Approved
Approval date:
Contact:

Institution Review Board of Albany College of Pharmacy

Status: Approved
Approval date:
Contact:

Institutional Review Board- King Saud University- College of Medicine