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:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-24 @ 7:04 PM
NCT ID:
NCT04098757
Eligibility Criteria:
Inclusion Criteria:
* patients not under pharmacological treatment for at least six months,
* patients with a new diagnosis of fibromyalgia (FM)
* hypovitaminosis D (vitamin D \<30 mg / ml) or patients already in oral supplementation with 1,000 IU / day. People with hypovitaminosis are treated with Vitamin D supplementation
* 30 - 65 years old
* female sex
* signature of informed consent
Exclusion Criteria:
* patients treated with active drugs on the neuroendocrine system
* intake of drugs that can influence skeletal metabolism
* addition of other fibromyalgia medicines other than those included in the study, during the observational period
* allergies to components of the food supplement used
* use of oral hypoglycemic agents
* participation in other studies
* recent acupuncture treatments elsewhere
* severe psychiatric or neurological disorders
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT04098757
Study Brief:
Protocol Section:
NCT04098757