Effect of Vitamin D Supplementation on Metabolic Parameters in Patients With Type 2 Diabetes and … (NCT07468721) | Clinical Trial Compass
CompletedNot Applicable
Effect of Vitamin D Supplementation on Metabolic Parameters in Patients With Type 2 Diabetes and Vitamin D Deficiency
Paraguay119 participantsStarted 2024-05-07
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in glycated hemoglobin (HbA1c)
Timeframe: Baseline and 3 months
Trial details
NCT IDNCT07468721
SponsorFaculty of Medical Sciences, Clinical Hospital