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The aim of this intervention clinical study are: evaluation the effect of vitamin D supplementation on anti-oxidant status, inflammation, insulin resistance in patients type 2 diabetes mellitus.
The research question is how the effect of vitamin D supplementation for 3 and 6 months on anti-oxidant status, inflammation and insulin resistance in patients type 2 diabetes mellitus.
The main tasks participants will be asked to do:
Treatments they'll be given:
Participant register: Patients type 2 DM aged > 18 years who went to the Community Health Centers Mampang were interviewed, filled out questionnaires, and gave informed consent.Interview by interviewers with at least high school education after being given training first by researchers.
The data is entered in a computer excel table by the researcher. Accuracy, completeness of registration data using the screening form.
Data that contains detailed descriptions of each variable used by the registry:
Standard Operating Procedures to address registry operations and analysis activities:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Vitamin D, dosage form chewable tablet, dosage 5000 IU, frequency every day, duration six months |
|
| control group | Placebo Comparator | Placebo (microcrystalline,calcium carbonate, sodium starch), dosage form chewable tablet, frequency every day, duration six month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D 5000 IU | Dietary Supplement | Intervention vitamin D 5000 IU per day, duration six months, dosage form chewable tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| level of Superoxide Dismutase (SOD) | SOD | Change from Baseline at 3 and 6 months |
| Interleukin-6 (IL-6) | IL-6 in monocyte: % (method immunoflowcytometry); | Change from Baseline at 3 and 6 months |
| pancreatic and duodenal homeobox 1(PDX-1) expression | PDX-1 expression : ct (method polymerase chain reaction /PCR); | Change from Baseline at 3 and 6 months |
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | HOMA-IR : formula (fasting insulin (μIU/mL) x fasting blood glucose (mg/dL)/405 | Change from Baseline at 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| vitamin D level | Vitamin D: ng/mL; | Change from Baseline at 3 and 6 months |
| (hemoglobin glycate) HbA1C | HbA1c: % ; | Change from Baseline at 3 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alvina Alvina | Universitas Trisakti | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Health Centers Kecamatan Mampang Prapatan | Jakarta | DKI Jakarta | 12720 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29883970 | Result | Mansournia MA, Ostadmohammadi V, Doosti-Irani A, Ghayour-Mobarhan M, Ferns G, Akbari H, Ghaderi A, Talari HR, Asemi Z. The Effects of Vitamin D Supplementation on Biomarkers of Inflammation and Oxidative Stress in Diabetic Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Horm Metab Res. 2018 Jun;50(6):429-440. doi: 10.1055/a-0630-1303. Epub 2018 Jun 8. | |
| 29945132 |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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The study was divided into two groups, the intervention group and the control group. The intervention group received vitamin D 5000 IU/day for 6 months and the control group received a placebo (contains microcrystalline, calcium carbonate, sodium starch) for 6 months
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| Placebo | Dietary Supplement | Placebo |
|
| fasting blood glucose | Fasting blood glucose: mg/dL ; | Change from Baseline at 3 and 6 months |
| fasting insulin | Fasting insulin: μIU/mL | Change from Baseline at 3 and 6 months |
| Result |
| Yu Y, Tian L, Xiao Y, Huang G, Zhang M. Effect of Vitamin D Supplementation on Some Inflammatory Biomarkers in Type 2 Diabetes Mellitus Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Ann Nutr Metab. 2018;73(1):62-73. doi: 10.1159/000490358. Epub 2018 Jun 26. |
| 25745497 | Result | Al-Sofiani ME, Jammah A, Racz M, Khawaja RA, Hasanato R, El-Fawal HA, Mousa SA, Mason DL. Effect of Vitamin D Supplementation on Glucose Control and Inflammatory Response in Type II Diabetes: A Double Blind, Randomized Clinical Trial. Int J Endocrinol Metab. 2015 Jan 10;13(1):e22604. doi: 10.5812/ijem.22604. eCollection 2015 Jan. |