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

NCT07468721 | Completed

• 1 other identifier: 392-2024
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Vitamin D Deficiency

Keywords

Type 2 diabetes; Vitamin D deficiency; HbA1c; Glycemic control; BMI; Cholecalciferol

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and 3 months

Study Arms (1)

Vitamin D supplementation

EXPERIMENTAL

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)

Interventions

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.

Vitamin D supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculty of Medical Sciences, Clinical Hospital: lead

Study Sites (1)

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

San Lorenzo, Central Department, 2169, Paraguay

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: May 7, 2024
• Primary Completion: September 30, 2024
• Study Completion: March 31, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)