Hospital de Clínicas, Facultad de Ciencias Médicas, Universidad Nacional de Asunción
San Lorenzo, Central Department, 2169, Paraguay
NCT Number: NCT07468721
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
San Lorenzo, Central Department, 2169, Paraguay
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Faculty of Medical Sciences, Clinical Hospital
Other
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
Acronym: VITD-DM2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07533539
Diabetes Mellitus, Diabetes Mellitus, Type 2
Seoul, South Korea
View Trial DetailsNCT07711834
Cognition Disorders, Cognitive Dysfunction
Harbin, Heilongjiang, China
View Trial DetailsNCT07692802
Diabetes Mellitus, Diabetes Mellitus, Type 2
Seongnam-si, Gyeonggi-do, South Korea
View Trial DetailsNCT07694115
Diabetes Mellitus, Diabetes Mellitus, Type 2
Ahmedabad, Ambawadi, India
View Trial Details