NCT06451016

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

3 years

First QC Date

May 29, 2024

Last Update Submit

June 13, 2024

Conditions

Graves Disease

Outcome Measures

Primary Outcomes (1)

  • Muscle Strength

    Hand Grip strength was measured using dynamometer

    base line and after 3months

Study Arms (2)

Vitamin D group

EXPERIMENTAL
Dietary Supplement: Vitamin D supplements

Control Group

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Vitamin D supplementsDIETARY_SUPPLEMENT

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

Vitamin D group
PlaceboDIETARY_SUPPLEMENT

Matching Placebo

Control Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Grave's Disease
  • either starting or about to start anti-thyroid medication (ATD)

You may not qualify if:

  • Chronic granulomatous disease
  • hypercalcemia
  • poor renal function (eGFR \< 45 ml/min)
  • the presence of malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Frontier Medical and Dental College

Abbottābād, KPK, Pakistan

Location

Frontier Dental

Abbottābād, Sindh, 75000, Pakistan

Location

MeSH Terms

Conditions

Graves Disease

Condition Hierarchy (Ancestors)

ExophthalmosOrbital DiseasesEye DiseasesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 29, 2024

First Posted

June 10, 2024

Study Start

January 1, 2021

Primary Completion

December 30, 2023

Study Completion

January 15, 2024

Last Updated

June 14, 2024

Record last verified: 2024-06

Locations

PA(2)