Who is sponsoring NCT05848544?

NCT05848544 is sponsored by Istituto Ortopedico Rizzoli.

What condition does NCT05848544 study?

NCT05848544 studies Fibromyalgia, Knee Osteoarthritis.

Is NCT05848544 still recruiting?

NCT05848544 is currently completed. Last updated 26 March 2025.

Last reviewed 2025-03-26 · How we verify

NCT05848544: KD-FM-OA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy of a Very Low Calories Ketogenic Diet in Obese Patients With Fibromyalgia or Symptomatic Knee Osteoarthritis

Completed NA Last updated 26 March 2025

What this trial tests

NA trial testing Very low-calorie ketogenic diet for patients with symptomatic knee osteoarthritis in Fibromyalgia in 40 participants. Completed in 31 December 2024.

Timeline

2 April 2021

Primary endpoint
31 December 2024

31 December 2024

Quick facts

Lead sponsor	Istituto Ortopedico Rizzoli
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	2 April 2021
Primary completion	31 December 2024
Estimated completion	31 December 2024
Sites	1 location across Italy

Drugs / interventions tested

Very low-calorie ketogenic diet for patients with symptomatic knee osteoarthritis
Very low-calorie ketogenic diet for patients with fibromyalgia

Conditions studied

Fibromyalgia — all drugs for Fibromyalgia →
Knee Osteoarthritis — all drugs for Knee Osteoarthritis →

Sponsor

Istituto Ortopedico Rizzoli — full company profile →

Who can join

Adults 18 to 65, any sex, with Fibromyalgia or Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Adult patients with fibromyalgia or symptomatic knee osteoarthritis and comorbid obesity eligible to a very low calories ketogenic diet will be enrolled in the pilot study

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy, Safety, and Tolerability of a Very Low-Calorie Ketogenic Diet in Women with Obesity and Symptomatic Knee Osteoarthritis: A Pilot Interventional Study.
Ciaffi J, Mancarella L, Pederzani G, Lisi L, et al · · 2024 · cited 9× · PMID 39408203 · DOI 10.3390/nu16193236
Efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional study.
Ciaffi J, Lisi L, Mari A, Mancarella L, et al · · 2023 · cited 5× · PMID 37502721 · DOI 10.3389/fnut.2023.1219321

Verify or expand the search:

Other recruiting trials for Fibromyalgia

Currently open trials in the same condition.

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NCT07465991 — The Effect of Digital Cognitive Behavioural Therapy for Insomnia on Physical Activity in Fibromyalgia · NA · recruiting

Other Istituto Ortopedico Rizzoli trials

Trials by the same sponsor.

NCT07590882 — Evaluation of Return to Sports Activity After Periacetabular Osteotomy: An Observational Study · enrolling by invitation
NCT07021222 — Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot (DARE-DiaF · NA · recruiting
NCT07360964 — Clear Cell Chondrosarcoma in Italy · NA · active not recruiting
NCT07140367 — "Transarterial Microembolization (TAME) in Inflammatory Knee Pathology" · recruiting
NCT07102875 — Ready to Sail 2: A Pilot Study of Sail-Assisted Telerehabilitation in Rare Skeletal Diseases · NA · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05848544 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Istituto Ortopedico Rizzoli
Last refreshed: 26 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05848544.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing