Clinical trial NCT05596383: Effects of Vitamin D Supplementation on SOD,IL-6 and Insulin Resistance in Type 2 Diabetes Mellitus (DM)
Official title: THE EFFECT OF VITAMIN D SUPPLEMENTATION ON IMPROVING PANCREAS BETA CELL FUNCTION IN TYPE 2 DIABETES MELLITUS: STUDY OF SOD,IL-6,PDX-1 EXPRESSION, and INSULIN RESISTANCE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type2 Diabetes Mellitus
Lead sponsor: Trisakti University
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: BASIC_SCIENCE

Brief summary: 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:

* interviews, filling the questionnaires, and giving informed consent after receiving an explanation by the researcher about the purpose of the research
* taking blood for screening examination which includes examination of Serum Glutamic Pyruvic Transaminase (SGPT), albumin, creatinine and blood Ca.
* participant who meet the inclusion and exclusion criteria, performed a physical examination (height and weight) and blood collection for examination 25(OH)D.
* Subjects/participant with vitamin D deficiency and insufficiency will be included in randomization, two groups: the group that received vitamin D3 5,000 IU and the group that received a placebo. Vitamin D 5000 IU and placebo taken daily for 6 months.
* Observations for 3 months and 6 months from the first time supplementation was given.

Treatments they'll be given:

* During the study, the subject's clinical condition will be monitored.
* Subject observations are monitored by telephone or google form to subject or their families

Detailed description: 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:

* Gender: differences in the nature, form, and biological function of men and women that determine differences in reproduction, by interview using a questionnaire and identity card.
* Duration DM: time from the first time being diagnosed DM until the start of the study, expressed in months
* Subject's age: calculated from the time the study began with the date of birth listed on the identity card.

Standard Operating Procedures to address registry operations and analysis activities:

* patient recruitment : Patients type 2 DM aged \> 18 years who went to the Community Health Centers Mampang were interviewed.
* data collection: using screening form
* data management : using table excel computer
* data analysis : using Statistical Package for the Social Sciences (SPSS) versi 23
* report for adverse event: using form adverse event Sample size assessment : formula for hypothesis testing the mean difference of two groups Plan for missing data : back up data Statistical analysis plan to address the primary and secondary objectives: normality test (kolmogorov Smirnov), test statistic (T independent test or Mann Whitney test, Anova test)

Eligibility criteria: Inclusion Criteria:

* male and female, aged \> 18 years
* period of DM ≤ 3 years
* using a single anti-diabetic drug (monotherapy)
* HbA1c \> 6,5%

Exclusion Criteria:

* receive insulin therapy
* kidney disease, liver disease
* pregnant and lactating women
* allergy history
* hypercalcemia history
* consumption of vitamin D in the last 3 months

Primary outcomes:
measure: level of Superoxide Dismutase (SOD)
timeFrame: Change from Baseline at 3 and 6 months
measure: Interleukin-6 (IL-6)
timeFrame: Change from Baseline at 3 and 6 months
measure: pancreatic and duodenal homeobox 1(PDX-1) expression
timeFrame: Change from Baseline at 3 and 6 months
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
timeFrame: Change from Baseline at 3 and 6 months
Secondary outcomes:
measure: vitamin D level
timeFrame: Change from Baseline at 3 and 6 months
measure: (hemoglobin glycate) HbA1C
timeFrame: Change from Baseline at 3 and 6 months
measure: fasting blood glucose
timeFrame: Change from Baseline at 3 and 6 months
measure: fasting insulin
timeFrame: Change from Baseline at 3 and 6 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Community Health Centers Kecamatan Mampang Prapatan
state: DKI Jakarta
Study officials:
affiliation: Universitas Trisakti
name: Alvina Alvina
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.