Type 2 Diabetes Mellitus (T2DM)VITD-DM2NCT07468721
Effect of Vitamin D Supplementation on Metabolic Parameters in Patients With Type 2 Diabetes and Vitamin D Deficiency
A study testing cholecalciferol (vitamin D3) in people with Type 2 Diabetes Mellitus (T2DM) and Vitamin D Deficiency, run by Faculty of Medical Sciences, Clinical Hospital at 1 site in Paraguay.
Trial summary
The goal of this clinical study is to learn whether vitamin D supplementation improves metabolic control in adults with type 2 diabetes mellitus who have vitamin D deficiency. The main questions it aims to answer are: Does vitamin D supplementation improve fasting glucose and glycated hemoglobin (HbA1c) levels in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Vitamin D Deficiency
- What is being tested?
- cholecalciferol (vitamin D3)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteParaguay
- Study dates
- 7 May 2024to 31 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) of both sexes.
- Diagnosis of type 2 diabetes mellitus (T2DM).
- Patients treated at the Endocrinology Service of the Hospital de Clínicas, Facultad de Ciencias Médicas, Universidad Nacional de Asunción (FCM-UNA), or in private clinical practice between May and September 2024.
- Serum 25-hydroxyvitamin D [25(OH)D] deficiency < 30 ng/mL.
- Participants who adhered to the prescribed vitamin D supplementation for a period of three months.
Who cannot join
- Patients with intestinal malabsorption disorders (e.g., celiac disease, Crohn's disease, or other disorders affecting calcium absorption).
- Pregnant women.
- Patients already taking vitamin D supplementation at the time of study initiation.
- Patients with chronic kidney disease.
- Patients with a history of bariatric surgery
Trial locations and contacts
1 site in 1 country.
Paraguay1 site
Hospital de Clínicas, Facultad de Ciencias Médicas, Universidad Nacional de Asunción
San Lorenzo, Central Department, 2169
About this study
Official title: Effect of Vitamin D Administration on Metabolic Parameters in Patients With Type 2 Diabetes and Vitamin D Deficiency: Experience From the Endocrinology Department of the Hospital de Clínicas (FCM/UNA) and Private Practice
The goal of this clinical study is to learn whether vitamin D supplementation improves metabolic control in adults with type 2 diabetes mellitus who have vitamin D deficiency.
The main questions it aims to answer are:
Read more
Does vitamin D supplementation improve fasting glucose and glycated hemoglobin (HbA1c) levels in patients with type 2 diabetes and vitamin D deficiency? Does vitamin D supplementation increase serum vitamin D concentrations in these patients?
Researchers will evaluate metabolic parameters before and after vitamin D supplementation to assess changes associated with correction of vitamin D deficiency.
Participants will:
Receive oral vitamin D supplementation (100,000 IU once monthly) for three months Have fasting glucose, HbA1c, body mass index (BMI), and serum vitamin D levels measured at baseline and after three months of supplementation.
Read the detailed description
Vitamin D deficiency is highly prevalent among individuals with type 2 diabetes mellitus and has been associated with alterations in glucose metabolism, insulin resistance, and systemic inflammation. Several studies suggest that vitamin D may play a role in pancreatic beta-cell function and insulin sensitivity; however, evidence regarding the metabolic effects of vitamin D supplementation in patients with diabetes remains inconsistent.
The aim of this study was to evaluate changes in metabolic parameters after correction of vitamin D deficiency in adults with type 2 diabetes mellitus.
This longitudinal single-arm interventional study included 119 consecutive adult patients with type 2 diabetes mellitus and confirmed vitamin D deficiency. Patients with conditions that could interfere with vitamin D metabolism or absorption, including chronic kidney disease, intestinal malabsorption syndromes, and pregnancy, were excluded.
Participants received oral cholecalciferol supplementation at a dose of 100,000 IU once monthly for three months. Clinical and biochemical parameters were evaluated at baseline and after the intervention period. Measurements included fasting glucose, glycated hemoglobin (HbA1c), body mass index (BMI), and serum vitamin D concentrations.
The study aimed to assess changes in metabolic control following vitamin D supplementation and to explore the potential role of correcting vitamin D deficiency in patients with type 2 diabetes mellitus.
- Being tested
- cholecalciferol (vitamin D3)
- Keywords
- Type 2 diabetes, Vitamin D deficiency, HbA1c, Glycemic control, BMI, Cholecalciferol
- Medical subject headings
- Diabetes Mellitus, Type 2, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferol (vitamin D3)Dietary supplement
Oral cholecalciferol administered at a dose of 100,000 IU once monthly for three months in adults with type 2 diabetes mellitus and vitamin D deficiency.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D supplementation | Experimental | Participants with type 2 diabetes mellitus and vitamin D deficiency receive oral vitamin D supplementation (cholecalciferol 100,000 IU once monthly) for three months. Receives: Dietary Supplement: cholecalciferol (vitamin D3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated hemoglobin (HbA1c)
Change in glycated hemoglobin (HbA1c) levels after vitamin D supplementation in adults with type 2 diabetes mellitus and vitamin D deficiency
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start7 May 2024
- Primary completion30 Sep 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Medical Sciences, Clinical Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Eugenia Ruiz Diaz Narvaez, Faculty of Medical Sciences, Clinical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468721
- Sponsor's protocol ID
- 392-2024
- Acronym
- VITD-DM2
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly available. Data may be available from the investigators upon reasonable request and subject to institutional and ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Administration on Metabolic Parameters in Patients With Type 2 Diabetes and Vitamin D Deficiency: Experience From the Endocrinology Department of the Hospital de Clínicas (FCM/UNA) and Private Practice
- ClinicalTrials.gov ID
- NCT07468721
- Acronym / sponsor ID
- VITD-DM2 / 392-2024
- Keywords
- Type 2 diabetes, Vitamin D deficiency, HbA1c, Glycemic control, BMI, Cholecalciferol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Faculty of Medical Sciences, Clinical HospitalUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 12 Mar 2026 (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 goal of this clinical study is to learn whether vitamin D supplementation improves metabolic control in adults with type 2 diabetes mellitus who have vitamin D deficiency.
The main questions it aims to answer are:
Does vitamin D supplementation improve fasting glucose and glycated hemoglobin (HbA1c) levels in patients with type 2 diabetes and vitamin D deficiency? Does vitamin D supplementation increase serum vitamin D concentrations in these patients?
Researchers will evaluate metabolic parameters before and after vitamin D supplementation to assess changes associated with correction of vitamin D deficiency.
Participants will:
Receive oral vitamin D supplementation (100,000 IU once monthly) for three months Have fasting glucose, HbA1c, body mass index (BMI), and serum vitamin D levels measured at baseline and after three months of supplementation.
Detailed description
Vitamin D deficiency is highly prevalent among individuals with type 2 diabetes mellitus and has been associated with alterations in glucose metabolism, insulin resistance, and systemic inflammation. Several studies suggest that vitamin D may play a role in pancreatic beta-cell function and insulin sensitivity; however, evidence regarding the metabolic effects of vitamin D supplementation in patients with diabetes remains inconsistent.
The aim of this study was to evaluate changes in metabolic parameters after correction of vitamin D deficiency in adults with type 2 diabetes mellitus.
This longitudinal single-arm interventional study included 119 consecutive adult patients with type 2 diabetes mellitus and confirmed vitamin D deficiency. Patients with conditions that could interfere with vitamin D metabolism or absorption, including chronic kidney disease, intestinal malabsorption syndromes, and pregnancy, were excluded.
Participants received oral cholecalciferol supplementation at a dose of 100,000 IU once monthly for three months. Clinical and biochemical parameters were evaluated at baseline and after the intervention period. Measurements included fasting glucose, glycated hemoglobin (HbA1c), body mass index (BMI), and serum vitamin D concentrations.
The study aimed to assess changes in metabolic control following vitamin D supplementation and to explore the potential role of correcting vitamin D deficiency in patients with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplementation | Experimental | Dietary Supplement: cholecalciferol (vitamin D3)Participants with type 2 diabetes mellitus and vitamin D deficiency receive oral vitamin D supplementation (cholecalciferol 100,000 IU once monthly) for three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (≥18 years) of both sexes.
- Diagnosis of type 2 diabetes mellitus (T2DM).
- Patients treated at the Endocrinology Service of the Hospital de Clínicas, Facultad de Ciencias Médicas, Universidad Nacional de Asunción (FCM-UNA), or in private clinical practice between May and September 2024.
- Serum 25-hydroxyvitamin D [25(OH)D] deficiency < 30 ng/mL.
- Participants who adhered to the prescribed vitamin D supplementation for a period of three months.
Key exclusion criteria (5 listed)
- Patients with intestinal malabsorption disorders (e.g., celiac disease, Crohn's disease, or other disorders affecting calcium absorption).
- Pregnant women.
- Patients already taking vitamin D supplementation at the time of study initiation.
- Patients with chronic kidney disease.
- Patients with a history of bariatric surgery
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 |
|---|---|---|
| cholecalciferol (vitamin D3)Oral cholecalciferol administered at a dose of 100,000 IU once monthly for three months in adults with type 2 diabetes mellitus and vitamin D deficiency. | Dietary supplement | Vitamin D supplementation |
Primary outcome
Change in glycated hemoglobin (HbA1c)
Time frame: Baseline and 3 months
Change in glycated hemoglobin (HbA1c) levels after vitamin D supplementation in adults with type 2 diabetes mellitus and vitamin D deficiency
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 12 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly available. Data may be available from the investigators upon reasonable request and subject to institutional and ethical approval.
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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 testing cholecalciferol (vitamin D3) in people with Type 2 Diabetes Mellitus (T2DM) and Vitamin D Deficiency, run by Faculty of Medical Sciences, Clinical Hospital at 1 site in Paraguay.
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 5 inclusion and 5 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 12 Mar 2026. 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 Paraguay. 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. 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?
Change in glycated hemoglobin (HbA1c) (time frame: Baseline and 3 months). 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 12 Mar 2026.