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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-12

Study Completion Date

2023-06-23

Brief Summary

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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

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Detailed Description

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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)

Conditions

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Type2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Vitamin D 5000 IU

Intervention Type DIETARY_SUPPLEMENT

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

control group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Vitamin D 5000 IU

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No