Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT02243800
Brief Summary:
Vitamin D plays a key role in the regulation of calcium metabolism and bone physiology and also presents immunomodulatory effects. In contrast to healthy individuals, macrophages and synoviocytes synovium of patients with rheumatoid arthritis (RA) have receptors for vitamin D. In vitro, 1,25 Vitamin D inhibits T cell proliferation and cytokine synthesis and decreases pro-inflammatory process. There is an inverse relationship, at least in some epidemiological studies, between the circulating levels of 25OH vitamin D and the occurrence and / or activity of RA. The hypothesis of our study is that natural vitamin D supplementation in patients with RA and a vitamin D deficiency (vitamin D \<30 ng / mL) improves functional disability.
Detailed Description:
This is an interventional, multicenter (13 rheumatology units) randomized, double-blinded study against placebo, lasting 24 weeks. The main objective is to demonstrate that treatment with cholecalciferol improves functional disability (HAQ) in patients with RA not in remission (DAS28 VS\> 2.6 and the investigator does not think to change the treatment in the 3 months after enrolment) and vitamin D deficiency (vitamin D \<30 ng / ml). Secondary objectives will be to examine whether there is a decrease in disease activity (tender joint count, swollen joint count, VAS, EVA activity, ESR, CRP, EULAR criteria, ACR), a decrease in fatigue (FACIT EVA - fatigue), improved quality of life (SF36, EMIR, PASS, MOS) and the impact of RA (RAID).
Study:
NCT02243800
Study Brief:
Protocol Section:
NCT02243800