Calcium fructoborate effect on systemic inflammation and dyslipidaemia markers in middle-aged people with primary osteoarthritis

Phase 1

Completed

• Conditions: Primary osteoarthritis; Musculoskeletal Diseases; Polyarthrosis

• Registration Number: ISRCTN46679573
• Lead Sponsor: atural Research, Ltd (Romania)

Brief Summary

2011 results in https://pubmed.ncbi.nlm.nih.gov/21607703/ (added 29/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-08-30
• Study Start: 2010-03-17
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Men and non-pregnant women
2. Aged 40 - 85 years
3. Primary OA of at least one knee as demonstrated by a radiological examination carried out within the previous 3 months
4. Body mass index (BMI) less than 28 and greater than 24.4 kg/m^2
5. Elevated blood levels of at least one inflammatory marker

Exclusion Criteria

1. Individuals with digestion problems
2. Subjects with a fever and/or under treatment with antibiotics
3. Subjects with fructose intolerance
4. Subjects taking any painkillers and/or vitamin B6
5. Subjects taking aspirin
6. Current use of non-steroidal anti-inflammatory drugs (NSAIDS) and acetominophen

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of biochemical parameters. Blood samples for biochemical analyses were taken from fasting venous blood in the morning at the start, and after 2 weeks of treatment. Commercial tubes without anticoagulant were used to collect blood for determination of biochemical parameters. Basic biochemical parameters, lipid profile (total cholesterol, high density lipoprotein [HDL-], low density lipoprotein [LDL-] cholesterol, and inflammatory markers (C-reactive protein [CRP], erythrocyte sedimentation rate [ERS] and fibrinogen) were analysed in serum by standard biochemical procedures using the Hitachi 911 automatic analyser and kits (Roche, Switzerland). Due to known correlations between selected markers, the following ratios were used for processing the data: CHOL/CRP and HDL/CRP.

Secondary Outcome Measures

Name	Time	Method
<br> In neurological literature on diabetic peripheral neuropathy, several neuropathic symptoms and signs scales have been developed, such as the Neurological Symptom Score, the extensive Neuropathy Symptom Profile, and the Neurological Disability Score [B]. These physician-based scales are used primarily in diabetic neuropathy trials in order to diagnose the absence or presence of peripheral neuropathy, although the Neurological Symptom Score does not emphasise actual severity of complaints. Furthermore, consensus guidelines have been published on quantitative sensory testing [B], and on standardised measures in diabetic neuropathy [B]. We used said guidelines to determine paresthesias numbness.<br><br> These were measured at the first visit in the day when study begun, and the next measure was done after 2 weeks.<br>