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

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.

Study Overview

• Status: Completed
• Conditions: Graves Disease
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Vitamin D supplements

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • KPK
    • Abbottābād, KPK, Pakistan
      • Frontier Medical and Dental College
  • Sindh
    • Abbottābād, Sindh, Pakistan, 75000
      • Frontier Dental

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group	Dietary supplement: Placebo; Matching Placebo
Experimental: Vitamin D group	Dietary supplement: Vitamin D supplements; 70 mcg/day (equal to 2800 IU) of cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Strength	Hand Grip strength was measured using dynamometer	base line and after 3months

Collaborators and Investigators

• Sponsor: Frontier Medical and Dental College, Abbotabad

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Eye Diseases; Endocrine System Diseases; Thyroid Diseases; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Graves Disease; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 3389

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No