Type2 Diabetes MellitusDMNCT05596383
Effects of Vitamin D Supplementation on SOD,IL-6 and Insulin Resistance in Type 2 Diabetes Mellitus (DM)
A study testing Vitamin D 5000 IU in people with Type2 Diabetes Mellitus, run by Trisakti University at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- Vitamin D 5000 IU
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Feb 2022to 23 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female, aged > 18 years
- period of DM ≤ 3 years
- using a single anti-diabetic drug (monotherapy)
- HbA1c > 6,5%
Who cannot join
- receive insulin therapy
- kidney disease, liver disease
- pregnant and lactating women
- allergy history
- hypercalcemia history
- consumption of vitamin D in the last 3 months
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Community Health Centers Kecamatan Mampang Prapatan
Jakarta, DKI Jakarta, 12720
About this study
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
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.
Read more
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
Read the 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)
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- Vitamin D 5000 IU, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D 5000 IUDietary supplement
Intervention vitamin D 5000 IU per day, duration six months, dosage form chewable tablet
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Vitamin D, dosage form chewable tablet, dosage 5000 IU, frequency every day, duration six months Receives: 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of Superoxide Dismutase (SOD)
SOD
Measured: Change from Baseline at 3 and 6 months
Interleukin-6 (IL-6)
IL-6 in monocyte: % (method immunoflowcytometry);
Measured: 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);
Measured: 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
Measured: Change from Baseline at 3 and 6 months
Secondary outcomes (4)
vitamin D level
Vitamin D: ng/mL;
Measured: Change from Baseline at 3 and 6 months
(hemoglobin glycate) HbA1C
HbA1c: % ;
Measured: Change from Baseline at 3 and 6 months
fasting blood glucose
Fasting blood glucose: mg/dL ;
Measured: Change from Baseline at 3 and 6 months
fasting insulin
Fasting insulin: μIU/mL
Measured: Change from Baseline at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start12 Feb 2022
- Primary completion23 Jun 2023 (estimated)
- Study completion23 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trisakti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr Alvina Alvina,SpPK, Trisakti University
- Investigators
- Alvina Alvina, Principal investigator, Universitas Trisakti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596383
- Sponsor's protocol ID
- Trisaktipatklin
- Acronym
- DM
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29883970Yu 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.
PubMed 29945132Al-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.
PubMed 25745497
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05596383
- Acronym / sponsor ID
- DM / Trisaktipatklin
- Conditions
- Type2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Trisakti UniversityUniversity, hospital or other
- Study start
- 12 Feb 2022 (actual)
- Primary completion
- 23 Jun 2023 (estimated)
- Study completion
- 23 Jun 2023 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Vitamin D 5000 IUVitamin D, dosage form chewable tablet, dosage 5000 IU, frequency every day, duration six months |
| control group | Placebo comparator | Dietary Supplement: PlaceboPlacebo (microcrystalline,calcium carbonate, sodium starch), dosage form chewable tablet, frequency every day, duration six month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male and female, aged > 18 years
- period of DM ≤ 3 years
- using a single anti-diabetic drug (monotherapy)
- HbA1c > 6,5%
Key exclusion criteria (6 listed)
- receive insulin therapy
- kidney disease, liver disease
- pregnant and lactating women
- allergy history
- hypercalcemia history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D 5000 IUIntervention vitamin D 5000 IU per day, duration six months, dosage form chewable tablet | Dietary supplement | Intervention group |
| PlaceboPlacebo | Dietary supplement | control group |
Primary outcome
level of Superoxide Dismutase (SOD)
Time frame: Change from Baseline at 3 and 6 months
SOD
Interleukin-6 (IL-6)
Time frame: Change from Baseline at 3 and 6 months
IL-6 in monocyte: % (method immunoflowcytometry);
pancreatic and duodenal homeobox 1(PDX-1) expression
Time frame: Change from Baseline at 3 and 6 months
PDX-1 expression : ct (method polymerase chain reaction /PCR);
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: Change from Baseline at 3 and 6 months
HOMA-IR : formula (fasting insulin (μIU/mL) x fasting blood glucose (mg/dL)/405
4 secondary outcomes
vitamin D level
Time frame: Change from Baseline at 3 and 6 months
(hemoglobin glycate) HbA1C
Time frame: Change from Baseline at 3 and 6 months
fasting blood glucose
Time frame: Change from Baseline at 3 and 6 months
fasting insulin
Time frame: Change from Baseline at 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Results publication: PubMed 29883970Mansournia 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.
- Results publication: PubMed 29945132Yu 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.
- Results publication: PubMed 25745497Al-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.
- Individual participant dataSharing planned: No
Related trials for Type2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alvina Alvina principal investigator
Universitas Trisakti
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D 5000 IU in people with Type2 Diabetes Mellitus, run by Trisakti University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of Superoxide Dismutase (SOD) (time frame: Change from Baseline at 3 and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05596383, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.