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

NCT05596383 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2023-04-12

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Vitamin D 5000 IU

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

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

  • Trisakti University

    lead OTHER

Principal Investigators

  • Alvina Alvina · Universitas Trisakti

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-12
Primary Completion
2023-06-23
Completion
2023-06-23

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05596383 on ClinicalTrials.gov