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Efect Supplementation Vitamin D in Diabetes Mellitus Type 2

Effect Supplementation Vitamin D on HbA1c, Insulin, HOMA-IR and VCAM-1 in Diabetes Mellitus Type 2

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07019415
Enrollment
92
Registered
2025-06-13
Start date
2024-08-06
Completion date
2025-03-30
Last updated
2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2 (T2DM)

Keywords

vitamin D supplementation, HbA1c, insulin, HOMA-IR, VCAM-1

Brief 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. 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

Interventions

DRUGPlacebo : calcium carbonate 500 mg, microcrystalline cellulose, magnesium stearate, sodium starch glycolate

this placebo group receive placebo tablet ( calcium carbonate 500 mg, microcrystalline cellulose, magnesium stearate, sodium starch glycolate )

DRUGVitamin D 5000 IU+ placebo

vitamin D 5000 IU + placebo in the experimental group

Sponsors

Trisakti University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Effect of vitamin D supplementation on VCAM-1baseline, 3 months and 6 monthsThe 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 HbA1cbaseline, 3 month and 6 monthThe control and experimental groups were measured at baseline, after 3 months and 6 months vitamin D supplementation on HbA1c level

Secondary

MeasureTime frameDescription
Effect of supplementation vitamin D on blood fasting insulinbaseline, 3 month, 6 monthThe control and experimental groups were measured at baseline, after 3 months and 6 months vitamin D supplementation on blood fasting insulin
Effect of vitamin D supplementation on HOMA-IRbaseline, 3 month, 6 monthThe control and experimental groups were measured at baseline, after 3 months and 6 months vitamin D supplementation on HOMA-IR

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026