ClinicalTrials.gov record NCT07130305
is There an Effect of Adding Body Vibration to Intake of Vitamin D on Some Outcomes of Familial Mediterranean Fever
is There an Effect of Addition of Body Vibration to Intake of Vitamin D on Some Outcomes of Familial Mediterranean Fever
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This randomized study compares standard treatment (daily vitamin D plus usual colchicine) with the same treatment plus whole-body vibration in adolescent girls with familial Mediterranean fever. The vibration group receives three 20-minute whole-body vibration sessions per week for six months in addition to daily vitamin D and colchicine. Bone density and several blood, muscle-strength, and functional fitness measures are assessed after six months.
What it is studying. The study is testing whether adding regular whole-body vibration sessions to standard care (daily vitamin D and colchicine) affects bone mineral density and related measures. Outcomes listed include lumbar spine bone mineral density (primary), bone mass z-score, serum 25-hydroxyvitamin D, osteoprotegerin, quadriceps torque, and functional tests such as standing long jump, 30-second sit-to-stand, and the Ruffier index, all measured after six months.
What the researchers hope to learn. To find out whether adding whole-body vibration to vitamin D plus colchicine changes bone density, vitamin D levels, a bone-related protein (osteoprotegerin), muscle strength, and functional or cardiorespiratory fitness measures in adolescent girls with FMF.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- whole body vibration plus usual care
- usual care
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- FMF adolecent girls ages 13 -17 years forty patients
Exclusion criteria
- cardiac problems renal problems liver problems diabetes brain problems
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants are assigned to one of two groups for six months: both groups receive vitamin D and their usual colchicine doses daily; the vibration group also receives whole-body vibration sessions three times per week, 20 minutes each. After six months the study measures bone mineral density at lumbar vertebrae 2–4, blood tests (including serum 25-hydroxyvitamin D and osteoprotegerin), quadriceps strength on the dominant side, and functional tests (standing long jump, 30-second sit-to-stand, Ruffier index). Procedures therefore include taking the assigned treatments, periodic blood draws, and physical performance testing. The registry does not list a full visit schedule or other participant services.
How the study is structured. Randomized, parallel-group, single-masked interventional trial. Participants are randomly assigned to one of two groups. Both groups receive daily vitamin D and their usual colchicine for six months; the experimental group also has three 20-minute whole-body vibration sessions per week for six months. Key outcomes are measured after six months.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in Egypt. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on familial Mediterranean fever
Important dates
- Study start
- May 8, 2025
- Primary completion
- Jan 8, 2026 (estimated)
- Study completion
- Jan 15, 2026 (estimated)
- Target enrollment
- 40 participants (estimated)
- Last updated on registry
- Aug 19, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Cairo University
- Principal investigator
- Ali Mohamed Ali ismail, lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University
Cairo University
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Ali MA Ismail, lecturer 📞 01005154209 ✉ ali.mohamed@pt.cu.edu.eg
- Ali Ismail ✉ allooka2012@gmail.com
Participating sites (1)
- Cairo UniversityRecruiting
Giza, Dokki · Egypt
- ali ismail, lecturer · 02 01005154209 · ali.mohamed@pt.cu.edu.eg
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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