Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT02986893
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65, inclusive
* Female
* Self-reported race of white or black
* Diagnosis of CIS with MRI consistent with MS, RRMS, or PPMS by McDonald 2010 criteria or SPMS by Lublin 2014 definition
* If the subject is receiving treatment with disease-modifying therapy, must be on that therapy for at least 3 months prior to randomization
* Willing and able to be randomized to dietary intervention with commitment to rigorously follow the dietary protocol and complete the necessary assessments over 6 months
Exclusion Criteria:
* MS exacerbation within 60 days of protocol start
* Intravenous corticosteroids within 60 days of protocol start
* Patients with severe medical or psychiatric illness that would interfere with their ability to comply with the protocol, or potentially cause the patient harm as determined by the treating physician
* Active smoking at the time of protocol start
* Taking supplements other than approved doses of vitamin D within 1 month of study start
* Pregnancy or planning pregnancy during the study period, breastfeeding
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02986893
Study Brief:
Protocol Section:
NCT02986893