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Completed

NCT Number: NCT07468721

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas, Facultad de Ciencias Médicas, Universidad Nacional de Asunción

San Lorenzo, Central Department, 2169, Paraguay

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Faculty of Medical Sciences, Clinical Hospital

Other

Registry information

Official study 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

Acronym: VITD-DM2

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

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.

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