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

NCT ID: NCT06451016

Last Updated: 2024-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-01-15

Brief Summary

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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.

Detailed Description

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Conditions

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Graves Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin D group

Group Type EXPERIMENTAL

Vitamin D supplements

Intervention Type DIETARY_SUPPLEMENT

70 mcg/day (equal to 2800 IU) of cholecalciferol

Control Group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Matching Placebo

Interventions

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Vitamin D supplements

70 mcg/day (equal to 2800 IU) of cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

Placebo

Matching Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frontier Medical and Dental College, Abbotabad

OTHER

Sponsor Role lead

Responsible Party

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Dr Saif ur Rehman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Frontier Medical and Dental College

Abbottābād, KPK, Pakistan

Site Status

Frontier Dental

Abbottābād, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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3389

Identifier Type: -

Identifier Source: org_study_id

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