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

Type2 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05596383
• Other study ID #: Trisaktipatklin
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 12, 2022
• Est. completion date: June 23, 2023

Study information

• Verified date: October 2022
• Source: Trisakti University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: June 23, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Vitamin D 5000 IU
Intervention vitamin D 5000 IU per day, duration six months, dosage form chewable tablet
• Placebo
Placebo

Locations

Country	Name	City	State
Indonesia	Community Health Centers Kecamatan Mampang Prapatan	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Trisakti University

Country where clinical trial is conducted

Indonesia, 

References & Publications (3)

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 Met — View 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 an — View 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of Superoxide Dismutase (SOD)	SOD	Change from Baseline at 3 and 6 months
Primary	Interleukin-6 (IL-6)	IL-6 in monocyte: % (method immunoflowcytometry);	Change from Baseline at 3 and 6 months
Primary	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
Primary	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	vitamin D level	Vitamin D: ng/mL;	Change from Baseline at 3 and 6 months
Secondary	(hemoglobin glycate) HbA1C	HbA1c: % ;	Change from Baseline at 3 and 6 months
Secondary	fasting blood glucose	Fasting blood glucose: mg/dL ;	Change from Baseline at 3 and 6 months
Secondary	fasting insulin	Fasting insulin: µIU/mL	Change from Baseline at 3 and 6 months