Effects of Vitamin D Supplementation on Muscle Function Among Grave's Disease Patients

Graves Disease Clinical Trial

Official title:

Effects of Vitamin D Supplementation on Muscle Function Among Grave's Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06451016
• Other study ID #: 3389
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 15, 2024

Study information

• Verified date: June 2024
• Source: Frontier Medical and Dental College, Abbotabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction:

A deficit in vitamin D may be involved in the development and presentation of Graves' disease (GD). Lack of vitamin D and GD are linked to deteriorating quality of life (QoL) and weakening of the muscles. Our goal was to look at the possible advantages of vitamin D supplementation for the improvement of thyroid-related QoL and muscle function in GD patients, as well as the possible drawbacks of anti-thyroid drugs (ATD).

Methodology:

A multicenter randomized controlled experiment with single-blinding was carried out with 48 patients who had been diagnosed with Graves' illness. The participants were split into two groups n=24 patients in each group. In addition to standard ATD, Group A received either 70 μg (2800 IU) of vitamin D daily or a corresponding placebo. Investigator measured muscular function and isometric strength at baseline, three, and nine months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 15, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Grave's Disease

• either starting or about to start anti-thyroid medication (ATD)

Exclusion Criteria:

• Chronic granulomatous disease

• hypercalcemia

• poor renal function (eGFR < 45 ml/min)

• the presence of malignant disease

Related Conditions & MeSH terms

• Graves Disease

Intervention

Dietary Supplement:
• Vitamin D supplements
70 mcg/day (equal to 2800 IU) of cholecalciferol
• Placebo
Matching Placebo

Locations

Country	Name	City	State
Pakistan	Frontier Dental	Abbottabad	Sindh
Pakistan	Frontier Medical and Dental College	Abbottabad	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Frontier Medical and Dental College, Abbotabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Strength	Hand Grip strength was measured using dynamometer	base line and after 3months