Effects of Vitamin D Supplementation on SOD,IL-6 and Insulin Resistance in Type 2 Diabetes Mellitus (DM) (DM)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Type2 Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Vitamin D 5000 IU

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)

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 12720
      • Community Health Centers Kecamatan Mampang Prapatan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Vitamin D, dosage form chewable tablet, dosage 5000 IU, frequency every day, duration six months	Dietary supplement: Vitamin D 5000 IU; Intervention vitamin D 5000 IU per day, duration six months, dosage form chewable tablet
Placebo Comparator: control group; Placebo (microcrystalline,calcium carbonate, sodium starch), dosage form chewable tablet, frequency every day, duration six month	Dietary supplement: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Trisakti University
• Investigators: Principal Investigator: Alvina Alvina, Universitas Trisakti

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2022
• Primary Completion (Anticipated): June 23, 2023
• Study Completion (Anticipated): June 23, 2023

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: Trisaktipatklin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No