Graves DiseaseNCT06451016
Effects of Vitamin D Supplementation on Muscle Function Among Grave's Disease Patients
A study testing Vitamin D supplements in people with Graves Disease, run by Frontier Medical and Dental College, Abbotabad at 2 sites in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Graves Disease
- What is being tested?
- Vitamin D supplements
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Jan 2021to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Grave's Disease
- either starting or about to start anti-thyroid medication (ATD)
Who cannot join
- Chronic granulomatous disease
- hypercalcemia
- poor renal function (eGFR < 45 ml/min)
- the presence of malignant disease
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Frontier Medical and Dental College
Abbottābād, KPK
Frontier Dental
Abbottābād, Sindh, 75000
About this study
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).
Read more
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.
- Conditions
- Graves Disease
- Being tested
- Vitamin D supplements, Placebo
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D supplementsDietary supplement
70 mcg/day (equal to 2800 IU) of cholecalciferol
PlaceboDietary supplement
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D group | Experimental | Not described Receives: Dietary Supplement: Vitamin D supplements |
| Control Group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
Hand Grip strength was measured using dynamometer
Measured: base line and after 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Jan 2021
- Primary completion30 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frontier Medical and Dental College, Abbotabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Saif ur Rehman, Frontier Medical and Dental College, Abbotabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451016
- Sponsor's protocol ID
- 3389
- Status last verified
- Jun 2024
- First submitted
- 29 May 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D Supplementation on Muscle Function Among Grave's Disease Patients
- ClinicalTrials.gov ID
- NCT06451016
- Acronym / sponsor ID
- 3389
- Conditions
- Graves Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Frontier Medical and Dental College, AbbotabadUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D group | Experimental | Dietary Supplement: Vitamin D supplements |
| Control Group | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Grave's Disease
- either starting or about to start anti-thyroid medication (ATD)
Key exclusion criteria (4 listed)
- Chronic granulomatous disease
- hypercalcemia
- poor renal function (eGFR < 45 ml/min)
- the presence of malignant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D supplements70 mcg/day (equal to 2800 IU) of cholecalciferol | Dietary supplement | Vitamin D group |
| PlaceboMatching Placebo | Dietary supplement | Control Group |
Primary outcome
Muscle Strength
Time frame: base line and after 3months
Hand Grip strength was measured using dynamometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D supplements in people with Graves Disease, run by Frontier Medical and Dental College, Abbotabad at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Strength (time frame: base line and after 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.