Diabetes Mellitus Type 2 (T2DM)NCT07019415
Efect Supplementation Vitamin D in Diabetes Mellitus Type 2
A study of Diabetes Mellitus Type 2 (T2DM), run by Trisakti University at 1 site in Indonesia.
Trial summary
This is double blind randomized controlled trial study using 92 subject with diabetes mellitus type 2divided into 2 group, one group as control and other group as vitamin D group. At the end of study the study subject only left 40 subjects in each group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2 (T2DM)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteIndonesia
- Study dates
- 6 Aug 2024to 30 Mar 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and females age 18 - 65 years old
- had been diagnosed T2DM,
- duration T2DM ≤ 3 year
- HbA1c > 6,5 %
- used single antidibetic
- were willing to follow the protocol of the study and were willing to participate in this study after receiving explanations, by signing informed consent.
Who cannot join
- used insulin therapy
- had liver disease, renal disease
- pregnant women, or breast feeding women
- alergy
- hypercalsemia
- had been consuming vitamin D in three months before the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Supplementation Vitamin D on HbA1c, Insulin, HOMA-IR and VCAM-1 in Diabetes Mellitus Type 2
This is double blind randomized controlled trial study using 92 subject with diabetes mellitus type 2divided into 2 group, one group as control and other group as vitamin D group. At the end of study the study subject only left 40 subjects in each group. Vitamin D group received vitamin D 5000 IU and the control group received calcium carbonate, microcrystalline cellulose, magnesium stearate, sodium starch glycolate for 6 months. The goal of this study was to determine whether suplmentation Vitamin D 5000 IU for 6 months have any effect on HbA1c, insulin, HOMA-IR nd VCAM-1 in Diabetes mellitus type 2
Read the detailed description
Both supplementation tablet were made in the same shape, color, odor and packaging. The study was conducted from August 2024 until March 2025. The inclusion criteria in this study were male and females age 18 - 65 years old, had been diagnosed T2DM, duration T2DM ≤ 3 year, HbA1c > 6,5 %, used single antidibetic, were willing to follow the protocol of the study, and were willing to participate in this study after receiving explanations, by signing informed consent. The exclusion criteria were used insulin therapy, had liver disease, renal, disease, pregnant women, or breast feeding women, alergy, hypercalsemia, had been consuming vitamin D in three months before the study. During the study semiquantitative recording of food frequency was carried out at the beginning of the study, after 3 month and 6 months supplementation.
Subjects who passed the initial screening (age, duration of T2DM, taking one type of oral antidiabetic drug) were subjected to laboratory screening consisting of albumin, SGPT, calcium, creatinine. Furthermore subjects who met the inclusion and exclusion criteria were randomized and examined for blood pressure, pulse rate, body weight, height, abdominal circumference followed by drawing venous blood samples. Blood sampling was performed 3 times, namely at the beginning of the study, after 3 months and 6 months supplementation. Subjects were asked to fast 12 hours before venous blood sampling. A 10 ml venous blood was drawn from each subject, made into serum and frozen at minus 20 degree Celcius for use in the simultaneous determination of fasting blood glucose, HbA1c, vitamin 25(OH)D, fasting insulin, HOMA-IR and VCAM-1 concentrations, after the total number of subjects was reached. In addition albumin, SGPT, calcium and creatinine were also examined to monitor adverse event. The determination of vitamin 25(OH)D was performed by method direct competitive chemiluminescent immunoassay (CLIA), determination of insulin was performed by method sandwich enzyme linked immunosorbent assay .(ELISA), while VCAM-1 was determined by enzyme immunoassay
- Conditions
- Diabetes Mellitus Type 2 (T2DM)
- Being tested
- Vitamin D 5000 IU+ placebo, Placebo : calcium carbonate 500 mg, microcrystalline cellulose, magnesium stearate, sodium starch glycolate
- Keywords
- vitamin D supplementation, HbA1c, insulin, HOMA-IR, VCAM-1
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D 5000 IU+ placeboDrug
vitamin D 5000 IU + placebo in the experimental group
Placebo : calcium carbonate 500 mg, microcrystalline cellulose, magnesium stearate, sodium starch glycolateDrug
this placebo group receive placebo tablet ( calcium carbonate 500 mg, microcrystalline cellulose, magnesium stearate, sodium starch glycolate )
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | this control group received placebo tablet Receives: Drug: Placebo : calcium carbonate 500 mg, microcrystalline cellulose, magnesium stearate, sodium starch glycolate |
| vitamin D 5000 IU | Experimental | this group were received vitamin D 5000 IU+placebo Receives: Drug: Vitamin D 5000 IU+ placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of vitamin D supplementation on VCAM-1
The control and experimental groups were measured at baseline, after 3 months and 6 months vitamin D supplementation on VCAM-1 level
Measured: baseline, 3 months and 6 months
Effect of Vitamin D supplementation on HbA1c
The control and experimental groups were measured at baseline, after 3 months and 6 months vitamin D supplementation on HbA1c level
Measured: baseline, 3 month and 6 month
Secondary outcomes (2)
Effect of supplementation vitamin D on blood fasting insulin
The control and experimental groups were measured at baseline, after 3 months and 6 months vitamin D supplementation on blood fasting insulin
Measured: baseline, 3 month, 6 month
Effect of vitamin D supplementation on HOMA-IR
The control and experimental groups were measured at baseline, after 3 months and 6 months vitamin D supplementation on HOMA-IR
Measured: baseline, 3 month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start6 Aug 2024
- Primary completion28 Feb 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2 (T2DM)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trisakti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pusparini Pusparini, Trisakti University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019415
- Sponsor's protocol ID
- Universitas Trisakti
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Supplementation Vitamin D on HbA1c, Insulin, HOMA-IR and VCAM-1 in Diabetes Mellitus Type 2
- ClinicalTrials.gov ID
- NCT07019415
- Acronym / sponsor ID
- Universitas Trisakti
- Conditions
- Diabetes Mellitus Type 2 (T2DM)
- Keywords
- vitamin D supplementation, HbA1c, insulin, HOMA-IR, VCAM-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Trisakti UniversityUniversity, hospital or other
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 13 Jun 2025 (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.
This is double blind randomized controlled trial study using 92 subject with diabetes mellitus type 2divided into 2 group, one group as control and other group as vitamin D group. At the end of study the study subject only left 40 subjects in each group. Vitamin D group received vitamin D 5000 IU and the control group received calcium carbonate, microcrystalline cellulose, magnesium stearate, sodium starch glycolate for 6 months. The goal of this study was to determine whether suplmentation Vitamin D 5000 IU for 6 months have any effect on HbA1c, insulin, HOMA-IR nd VCAM-1 in Diabetes mellitus type 2
Detailed description
Both supplementation tablet were made in the same shape, color, odor and packaging. The study was conducted from August 2024 until March 2025. The inclusion criteria in this study were male and females age 18 - 65 years old, had been diagnosed T2DM, duration T2DM ≤ 3 year, HbA1c > 6,5 %, used single antidibetic, were willing to follow the protocol of the study, and were willing to participate in this study after receiving explanations, by signing informed consent. The exclusion criteria were used insulin therapy, had liver disease, renal, disease, pregnant women, or breast feeding women, alergy, hypercalsemia, had been consuming vitamin D in three months before the study. During the study semiquantitative recording of food frequency was carried out at the beginning of the study, after 3 month and 6 months supplementation.
Subjects who passed the initial screening (age, duration of T2DM, taking one type of oral antidiabetic drug) were subjected to laboratory screening consisting of albumin, SGPT, calcium, creatinine. Furthermore subjects who met the inclusion and exclusion criteria were randomized and examined for blood pressure, pulse rate, body weight, height, abdominal circumference followed by drawing venous blood samples. Blood sampling was performed 3 times, namely at the beginning of the study, after 3 months and 6 months supplementation. Subjects were asked to fast 12 hours before venous blood sampling. A 10 ml venous blood was drawn from each subject, made into serum and frozen at minus 20 degree Celcius for use in the simultaneous determination of fasting blood glucose, HbA1c, vitamin 25(OH)D, fasting insulin, HOMA-IR and VCAM-1 concentrations, after the total number of subjects was reached. In addition albumin, SGPT, calcium and creatinine were also examined to monitor adverse event. The determination of vitamin 25(OH)D was performed by method direct competitive chemiluminescent immunoassay (CLIA), determination of insulin was performed by method sandwich enzyme linked immunosorbent assay .(ELISA), while VCAM-1 was determined by enzyme immunoassay
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Placebo : calcium carbonate 500 mg, microcrystalline cellulose, magnesium stearate, sodium starch glycolatethis control group received placebo tablet |
| vitamin D 5000 IU | Experimental | Drug: Vitamin D 5000 IU+ placebothis group were received vitamin D 5000 IU+placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male and females age 18 - 65 years old
- had been diagnosed T2DM,
- duration T2DM ≤ 3 year
- HbA1c > 6,5 %
- used single antidibetic
Key exclusion criteria (6 listed)
- used insulin therapy
- had liver disease, renal disease
- pregnant women, or breast feeding women
- alergy
- hypercalsemia
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 IU+ placebovitamin D 5000 IU + placebo in the experimental group | Drug | vitamin D 5000 IU |
| Placebo : calcium carbonate 500 mg, microcrystalline cellulose, magnesium stearate, sodium starch glycolatethis placebo group receive placebo tablet ( calcium carbonate 500 mg, microcrystalline cellulose, magnesium stearate, sodium starch glycolate ) | Drug | control group |
Primary outcome
Effect of vitamin D supplementation on VCAM-1
Time frame: baseline, 3 months and 6 months
The control and experimental groups were measured at baseline, after 3 months and 6 months vitamin D supplementation on VCAM-1 level
Effect of Vitamin D supplementation on HbA1c
Time frame: baseline, 3 month and 6 month
The control and experimental groups were measured at baseline, after 3 months and 6 months vitamin D supplementation on HbA1c level
2 secondary outcomes
Effect of supplementation vitamin D on blood fasting insulin
Time frame: baseline, 3 month, 6 month
Effect of vitamin D supplementation on HOMA-IR
Time frame: baseline, 3 month, 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetes Mellitus Type 2 (T2DM), 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 6 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: finished, as of the sponsor's last update on 13 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of vitamin D supplementation on VCAM-1 (time frame: baseline, 3 months and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2025.