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

NCT05596383 | Unknown

• 1 other identifier: Trisaktipatklin
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• vitamin D level

  Change from Baseline at 3 and 6 months

• (hemoglobin glycate) HbA1C

  Change from Baseline at 3 and 6 months

• fasting blood glucose

  Change from Baseline at 3 and 6 months

• fasting insulin

  Change from Baseline at 3 and 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Vitamin D, dosage form chewable tablet, dosage 5000 IU, frequency every day, duration six months

Dietary Supplement: Vitamin D 5000 IU

control group

PLACEBO COMPARATOR

Placebo (microcrystalline,calcium carbonate, sodium starch), dosage form chewable tablet, frequency every day, duration six month

Dietary Supplement: Placebo

Interventions

Vitamin D 5000 IU DIETARY_SUPPLEMENT

Intervention vitamin D 5000 IU per day, duration six months, dosage form chewable tablet

Intervention group

Placebo DIETARY_SUPPLEMENT

Placebo

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Trisakti University: lead

Study Sites (1)

Community Health Centers Kecamatan Mampang Prapatan

Jakarta, DKI Jakarta, 12720, Indonesia

Location

Related Publications (3)

• 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.

  PMID: 29883970 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.

  PMID: 29945132 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.

  PMID: 25745497 RESULT

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Alvina Alvina

  Universitas Trisakti

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pathology specialist

Model Details: 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

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 27, 2022
• Study Start: February 12, 2022
• Primary Completion: June 23, 2023
• Study Completion: June 23, 2023
• Last Updated: April 12, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)