Actively Recruiting

Phase Not Applicable
Age: 13Years - 17Years
FEMALE
ID07130305

Effect of Adding Whole Body Vibration to Vitamin D Intake on Outcomes in Adolescent Girls with Familial Mediterranean Fever

Led by Cairo University · Updated on 2025-08-19

40

Participants Needed

1

Research Sites

1 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Familial Mediterranean Fever (FMF) is a condition common in the Mediterranean region that affects adolescents, leading to reduced physical function, cardiorespiratory fitness, muscle strength, and bone mass. This research aims to explore whether adding whole body vibration therapy to the usual vitamin D and colchicine treatment can improve these health outcomes in adolescent girls with FMF. The study involves two groups of 20 adolescent girls with FMF each. Both groups will receive daily vitamin D supplements and their regular colchicine medication for six months. One group, called the vibration group, will also participate in three 20-minute sessions of whole body vibration each week during the same six-month period, while the control group will receive only the vitamin D and colchicine treatment. Participants will be monitored over six months, with assessments including bone mineral density, vitamin D levels, osteoprotegerin, quadriceps muscle strength, and physical performance tests like the standing long jump and sit-to-stand tests. These measurements will help researchers evaluate the impact of adding whole body vibration to standard care. The study includes randomized assignment to groups and single masking to maintain study integrity, with participation lasting six months from start to finish.

CONDITIONS

Brief Title

is There an Effect of Adding Body Vibration to Intake of Vitamin D on Some Outcomes of Familial Mediterranean Fever

Who Can Participate

Age: 13Years - 17Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female adolescents aged 13 to 17 years
  • Diagnosed with Familial Mediterranean Fever
  • Total of 40 participants (20 per group)
  • Currently receiving colchicine and vitamin D treatment
Not Eligible

You will not qualify if you...

  • History of cardiac problems
  • History of renal (kidney) problems
  • History of liver problems
  • History of diabetes
  • History of brain problems

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants receive daily vitamin D and colchicine treatment for six months. Those in the vibration group also attend three 20-minute whole body vibration sessions per week during this time.

Weekly visits for progress assessments and vibration sessions as applicable

Trial Site Locations

Total: 1 location

1

Cairo University

Giza, Dokki, Egypt

Actively Recruiting

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Research Team

A

Ali MA Ismail, lecturer

A

Ali Ismail

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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