NCT07468721

Effect of Vitamin D Supplementation on Metabolic Parameters in Patients With Type 2 Diabetes and Vitamin D Deficiency

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Faculty of Medical Sciences, Clinical Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Type 2 Diabetes Mellitus (T2DM)
• Vitamin D Deficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-07
• Primary completion: 2024-09-30
• Completion: 2025-03-31
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: Paraguay