Kre-Celazine^® as a Viable Treatment for Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis — A Pilot Study

Abstract

The purpose of this study was to ascertain whether an oral, non-prescription, nutritional supplement compound composed of a proprietary alkali-buffered creatine monohydrate and cetylated fatty acids mixture (Kre-Celazine(®)) was efficacious in reducing or eliminating refractory pain and inflammation, without untoward effects, in Juvenile Rheumatoid Arthritis (JRA), which is also called Juvenile Idiopathic Arthritis (JIA). JRA/JIA is a patho-physiologically complex, chronic childhood autoimmune inflammatory disease of unknown etiology. Numerous studies have unsuccessfully attempted to pinpoint a possible common initiation event. Officially considered an affliction of children below the age of 16 years, an initial diagnosis has been confirmed in infants less than 1 year old, to individuals older then 17 years. In this study, sixteen juveniles, ages 7 through 16 years, experiencing long-standing, unremitting pain and inflammation despite previous use of prescription anti-inflammatory drugs and NSAIDs, were enrolled in a 30-day, open-label clinical study and treated with Kre-Celazine. Efficacy of this nutritional supplement was determined by the juvenile's personal physician and based on observations of the following: (1) significant reduction or elimination of palpable signs of inflammation; (2) renormalization of range of motion; (3) reduction or absence of perceived pain as reported to the physician by the patient; (4) renormalization of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) values. In addition, the individual's previous steroid or non-steroidal anti-inflamatory medication(s) were reduced or eliminated in a stepwise progressive fashion during the study.

An investigation into the relationship between nutritional status, dietary intake, symptoms and health-related quality of life in children and young people with juvenile idiopathic arthritis: a systematic review and meta-analysis

“…( p = 0.621, 0.166 respectively) Golini and Jones. 2014 [ 21 ] Total:16 Clinical trial Kre-Celazine nutritional Supplement composed of a proprietary alkali buffered creatine monohydrate and acetylated fatty acids mixture Normal range of motion Decreased ESR and CRP Decreased pain scores Gheita et al 2012 [ 22 ] Total:47 JIA:27 Control:20 Controlled trial Dietary supplements of omega-3 FAs A remarkable improvement in: mean active joint count ( p < 0.001) JADAS-27 ( p < 0.001) CHAQ ( p < 0.001) A significant reduction in the ESR Yarema et al 2018 [ 23 ] Total:68 JIA:53 Control:15 Randomised controlled trial Dietary supplements of omega-3 PUFA Immune status significantly improved:(≤ 0.05) Berntson et al2014 [ 24 ] 1 case study Full nutrition by EEN Improvement in: global assessment of pain (VAS 0–100 mm) CHAQ JADAS 27 Berntson et al2016 [ 24 ] 1 Pilot study Full nutrition by EEN A remarkable Improvement in: number of inflamed joints, morning stiffness, global assessment of pain (VAS 0–100 mm) CHAQ Berntson et al2016 [ 24 ] 7 Exploratory study Full nutrition by EEN An immediate anti-inflammatory effect, as shown by reduction in inflammatory Proteins MCP-2, MCP-3 and MCP-4 (monocyte chemoattractant protein) resulting in clinical improvement in patients with JIA and decreased in levels of JADAS27, CHAQ and pain VAS …”

“…From the randomised trials, one study [ 20 ] had an overall low risk of bias, and two had some concern [ 19 , 23 ], while the remaining trials [ 12 , 21 , 22 ] had an overall high concern. For the cross-sectional studies, overall, four studies had good quality [ 9 , 33 , 36 , 38 ] while others were fair [ 10 , 32 , 34 , 35 , 37 , 39 ].…”

An investigation into the relationship between dietary intake, symptoms and health- related quality of life in children and young people with juvenile idiopathic arthritis: A systematic review and meta-analysis

“…From the randomised trials, one study (17) had an overall low risk of bias and two had some concern (18, 19) while the remaining trials (10,20,21) had an overall high concern. For the cross-sectional studies, overall four studies had good quality (22,23,24,25) while others were fair (1,26,27,28,29,31).…”

“…Berntson et al (37,38), in one case and one pilot study with one participant and Golini (20) in a clinical trial study with 16 participants reported that in ammation, pain and disease activity improved after treatment with EEN(37,38) which contains protein and Kre-Celazine nutritional supplement composed of a proprietary alkali buffered, creatine monohydrate and fatty acids mixture (20).…”

The effect of an alkaline buffered creatine (Kre-Alkalyn®), on cell membrane behavior, protein synthesis, and cisplatin-mediated cellular toxicity

“…Alkaline buffered supplements have been shown to have an antiproliferative effect in human tumor cells more so than non-buffered supplements [20], and may be effective in the treatment of juvenile arthritis [21]. Extracellular alterations in pH around the immediate cell membrane, especially in neoplastic cell models, have been shown capable of affecting the behavior of cell membrane/surface receptors.…”