Familial Mediterranean FeverNCT07130305
is There an Effect of Adding Body Vibration to Intake of Vitamin D on Some Outcomes of Familial Mediterranean Fever
A study of Familial Mediterranean Fever, run by Cairo University at 1 site in Egypt.
Trial summary
Familial mediterranean fever (FMF) is common in mediterranean region. this disorder is connected with deterioration in functional performance, fitness of cardiorespiration, muscle strength, and bone mass Read more about this study
- Who is it for?
- Ages 13 to 17 years, women only
- Conditions the study is for
- Familial Mediterranean Fever
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 8 May 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- FMF adolecent girls ages 13 -17 years forty patients
Who cannot join
- cardiac problems renal problems liver problems diabetes brain problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ali Ismail contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza, Dokki
ali ismail, lecturer, 02 01005154209, ali.mohamed@pt.cu.edu.eg
About this study
Official title: is There an Effect of Addition of Body Vibration to Intake of Vitamin D on Some Outcomes of Familial Mediterranean Fever
Familial mediterranean fever (FMF) is common in mediterranean region. this disorder is connected with deterioration in functional performance, fitness of cardiorespiration, muscle strength, and bone mass
Read the detailed description
Familial mediterranean fever (FMF adolescent girls ) will be collected to be cateogarized to vibration group (vibration group) or control grouping. every group OF FMF will contain 20 FMF adolescent girls. both groups will receive vitamin D and their traditional colchicine doses daily for six months. vibration group will receive three sessions of 20-min whole body vibration in the week for 6 months
- Conditions
- Familial Mediterranean Fever
- Being tested
- whole body vibration plus usual care, usual care
- Medical subject headings
- Familial Mediterranean Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibration plus usual careOther
Familial mediterranean fever (20 FMF adolescent girls ) will be in this vibration group who will receive vitamin D and their traditional colchicine doses daily for six months. vibration group will also receive three sessions of 20-min whole body vibration in the week for 6 months
usual careOther
Familial mediterranean fever (20 FMF adolescent girls ) will be in this control group who will receive vitamin D and their traditional colchicine doses daily for six months.
| Study group | Role | What they receive |
|---|---|---|
| vibration group | Experimental | vibration group OF FMF will contain 20 FMF adolescent girls. who will receive vitamin D and their traditional colchicine doses daily for six months. vibration group will receive also three sessions of 20-min whole body vibration in the week for 6 months Receives: Other: whole body vibration plus usual care |
| control group | Active comparator | control group of Familial mediterranean fever (20 FMF adolescent girls ) will receive vitamin D and their traditional colchicine doses daily for six months. Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density
it is a measure for bone density at 2-4 lumbar vertebrae
Measured: it will be measured after 6 months
Secondary outcomes (7)
z score
it is a score for measure for bone mass at 2-4 lumbar vertebrae
Measured: it will be measured after 6 months
vitamin D
it will measured in plasma as serum 25-hydroxyvitamin D
Measured: it will be measured after 6 months
osteoprotegerin
it will measured in plasma
Measured: it will be measured after 6 months
quadriceps torque
it will measured in dominant side
Measured: it will be measured after 6 months
Standing long jump test
it is an indicator for functional performance
Measured: it will be measured after 6 months
Thirty second sit to stand test
it is an indicator for functional performance
Measured: it will be measured after 6 months
Ruffier index
it is an indicator for cardiorespirtory fittness
Measured: it will be measured after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start8 May 2025
- Primary completion8 Jan 2026 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean FeverStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali MA Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130305
- Sponsor's protocol ID
- IRB00014233-33
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- is There an Effect of Addition of Body Vibration to Intake of Vitamin D on Some Outcomes of Familial Mediterranean Fever
- ClinicalTrials.gov ID
- NCT07130305
- Acronym / sponsor ID
- IRB00014233-33
- Conditions
- Familial Mediterranean Fever
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- 8 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 19 Aug 2025 (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.
Familial mediterranean fever (FMF) is common in mediterranean region. this disorder is connected with deterioration in functional performance, fitness of cardiorespiration, muscle strength, and bone mass
Detailed description
Familial mediterranean fever (FMF adolescent girls ) will be collected to be cateogarized to vibration group (vibration group) or control grouping. every group OF FMF will contain 20 FMF adolescent girls. both groups will receive vitamin D and their traditional colchicine doses daily for six months. vibration group will receive three sessions of 20-min whole body vibration in the week for 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vibration group | Experimental | Other: whole body vibration plus usual carevibration group OF FMF will contain 20 FMF adolescent girls. who will receive vitamin D and their traditional colchicine doses daily for six months. vibration group will receive also three sessions of 20-min whole body vibration in the week for 6 months |
| control group | Active comparator | Other: usual carecontrol group of Familial mediterranean fever (20 FMF adolescent girls ) will receive vitamin D and their traditional colchicine doses daily for six months. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- FMF adolecent girls ages 13 -17 years forty patients
Key exclusion criteria (1 listed)
- cardiac problems renal problems liver problems diabetes brain problems
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 |
|---|---|---|
| whole body vibration plus usual careFamilial mediterranean fever (20 FMF adolescent girls ) will be in this vibration group who will receive vitamin D and their traditional colchicine doses daily for six months. vibration group will also receive three sessions of 20-min whole body vibration in the week for 6 months | Other | vibration group |
| usual careFamilial mediterranean fever (20 FMF adolescent girls ) will be in this control group who will receive vitamin D and their traditional colchicine doses daily for six months. | Other | control group |
Primary outcome
bone mineral density
Time frame: it will be measured after 6 months
it is a measure for bone density at 2-4 lumbar vertebrae
7 secondary outcomes
z score
Time frame: it will be measured after 6 months
vitamin D
Time frame: it will be measured after 6 months
osteoprotegerin
Time frame: it will be measured after 6 months
quadriceps torque
Time frame: it will be measured after 6 months
Standing long jump test
Time frame: it will be measured after 6 months
Thirty second sit to stand test
Time frame: it will be measured after 6 months
Ruffier index
Time frame: it will be measured after 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
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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.
Ali Ismail contact
Ali MA Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Familial Mediterranean Fever, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali MA Ismail, lecturer (01005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone mineral density (time frame: it will be measured after 6 months). 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 19 Aug 2025.