An interventional study of cholecalciferol (vitamin D3) in Type 2 Diabetes Mellitus (T2DM) and Vitamin D Deficiency, sponsored by Faculty of Medical Sciences, Clinical Hospital. Completed at 1 site in Paraguay. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Faculty of Medical Sciences, Clinical Hospital · Not applicable, Interventional, and Treatment
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 119 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Faculty of Medical Sciences, Clinical Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Participants with type 2 diabetes mellitus and vitamin D deficiency receive oral vitamin D supplementation (cholecalciferol 100,000 IU once monthly) for three months.
Dietary Supplement: 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.
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
Time frame: Baseline and 3 months
Plan to share: 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.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholecalciferol
Faculty of Medical Sciences, Clinical Hospital