Efect Supplementation Vitamin D in Diabetes Mellitus Type 2

NCT07019415 | Completed

• 1 other identifier: Universitas Trisakti
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 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

Conditions

Diabetes Mellitus Type 2 (T2DM)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  baseline, 3 month and 6 month

Secondary Outcomes (2)

• Effect of supplementation vitamin D on blood fasting insulin

  baseline, 3 month, 6 month

• Effect of vitamin D supplementation on HOMA-IR

  baseline, 3 month, 6 month

Study Arms (2)

control group

PLACEBO COMPARATOR

this control group received placebo tablet

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

Drug: Vitamin D 5000 IU+ placebo

Interventions

Vitamin D 5000 IU+ placebo DRUG

vitamin D 5000 IU + placebo in the experimental group

vitamin D 5000 IU

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

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

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trisakti University: lead

Study Sites (1)

Trisakti University

Jakarta, DKI Jakarta, 11710, Indonesia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Vitamin D; microcrystalline cellulose; stearic acid; sodium starch glycolate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.dr. Pusparini, Sp.PK, subsp.K.V.(K)

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 13, 2025
• Study Start: August 6, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 30, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)