Nutrition Habits in Multiple SclerosisNCT04110171
Relationship Between the Nutritional Habits and Relapsing and Disability Rates in Patient With Multiple Sclerosis.
An observational study of Nutrition Habits in Multiple Sclerosis, run by Assiut University.
Trial summary
patient with multiple sclerosis will undergo and completed comprehensive survey measuring body mass index and assessment of obesity ,health related quality of life,disability,relapsing and complete data on their dietary habits. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition Habits in Multiple Sclerosis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 Dec 2021
- Phase
- Observational
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: patient 20 and 40 years ago with both gender diagnosed with multiple sclerosis under treatment or not
Who may be able to join
- 20 to 40 years of age
- males or females
- all cases of diagnosed multiple sclerosis under treatment or not
Who cannot join
- disable cases
- long standing disease more than five years.
About this study
Official title: Relationship Between the Nutritional Habits and Relapsing and Disability Rates in Patient With
patient with multiple sclerosis will undergo and completed comprehensive survey measuring body mass index and assessment of obesity ,health related quality of life,disability,relapsing and complete data on their dietary habits.
- Conditions
- Nutrition Habits in Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of the body mass index and so assessment of obesity of the patient and multiple sclerosis . also assessment of nutrition habits by dietary habits questionnaire in theses patient .
dietary habits questionnaire include
- family eating habits
- personal dietary assessment personal eating habits
- personal back ground information The questionnaire considers both the type of food consumed and the methods of food preparation. Each item scores from 1 to 5 with a score of 1 indicating very poor dietary behavior and a score of 5 indicating healthy.These items give rise to 10 dietary sub scores: cereals, fruit and vegetables, omega-3 fatty acids, food choices, food preparation, takeaways and snacks, fat, fiber, sodium, Mean scores ranging from 1 to 5 are calculated for each sub score
Measured: one and half year
assessment of disability rates of the patient of multiple sclerosis.
the disability rate assessed by expanded disability status scale which is a self-reported surrogate tool used by neurologists to assess gait disability.33,34 Th scored ordinally from 0 (normal) to 8 (bed bound).
bound)
Measured: one and half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition Habits in Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Abd alazeem Moustafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110171
- Sponsor's protocol ID
- nutritional habits in multiple
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2019
- Last updated
- 1 Oct 2019
- 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 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the Nutritional Habits and Relapsing and Disability Rates in Patient With
- ClinicalTrials.gov ID
- NCT04110171
- Acronym / sponsor ID
- nutritional habits in multiple
- Conditions
- Nutrition Habits in Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 1 Oct 2019 (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.
patient with multiple sclerosis will undergo and completed comprehensive survey measuring body mass index and assessment of obesity ,health related quality of life,disability,relapsing and complete data on their dietary habits.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patient 20 and 40 years ago with both gender diagnosed with multiple sclerosis under treatment or not
Key inclusion criteria (3 listed)
- 20 to 40 years of age
- males or females
- all cases of diagnosed multiple sclerosis under treatment or not
Key exclusion criteria (2 listed)
- disable cases
- long standing disease more than five years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
measurement of the body mass index and so assessment of obesity of the patient and multiple sclerosis . also assessment of nutrition habits by dietary habits questionnaire in theses patient .
Time frame: one and half year
dietary habits questionnaire include * family eating habits * personal dietary assessment personal eating habits * personal back ground information The questionnaire considers both the type of food consumed and the methods of food preparation. Each item scores from 1 to 5 with a score of 1 indicating very poor dietary behavior and a score of 5 indicating healthy.These items give rise to 10 dietary sub scores: cereals, fruit and vegetables, omega-3 fatty acids, food choices, food preparation, takeaways and snacks, fat, fiber, sodium, Mean scores ranging from 1 to 5 are calculated for each sub score
assessment of disability rates of the patient of multiple sclerosis.
Time frame: one and half year
the disability rate assessed by expanded disability status scale which is a self-reported surrogate tool used by neurologists to assess gait disability.33,34 Th scored ordinally from 0 (normal) to 8 (bed bound). bound)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition Habits in Multiple Sclerosis, run by Assiut University.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
measurement of the body mass index and so assessment of obesity of the patient and multiple sclerosis . also assessment of nutrition habits by dietary habits questionnaire in theses patient . (time frame: one and half year). The study lists 2 primary outcomes in all. 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 1 Oct 2019.