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ISRCTN
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ISRCTN46679573
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ClinicalTrials.gov identifier
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Public title
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Calcium fructoborate effect on systemic inflammation and dyslipidaemia markers in middle-aged people with primary osteoarthritis
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Scientific title
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A double-blind, placebo-controlled pilot study to evaluate FruitexB® (calcium fructoborate) effect on systemic inflammation and dyslipidaemia markers in middle-aged people with primary osteoarthritis
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Acronym
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FruiteB
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Serial number at source
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Research Project no.12/2008
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Study hypothesis
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The safe and efficacious use of the FruitexB® (chemical natural-identical plant based dietary boron) in other inflammatory diseases prompted us to do this study of its anti-inflammatory effects in patients with osteoarthritis (OA) symptoms. The main objective of this approach was to evaluate whether or not FruitexB®, in a double-blind, placebo-controlled, randomly allocated trial with patients suffering from knee osteoarthritis symptoms, may cause any statistically significant favourable effect on systemic inflammation and dyslipidemia markers when compared with the placebo group.
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Lay summary
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Ethics approval
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Institutional Ethics Committee of the University of Medicine and Pharmacy of Craiova, Romania, approved in March 2008 (ref: 364/2008). The trial is also in compliance with the Helsinki Declaration of 1975 as revised in 1983.
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Study design
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Randomised double-blind placebo-controlled single centre trial
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Countries of recruitment
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Romania
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Disease/condition/study domain
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Primary osteoarthritis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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10/03/2008
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Anticipated end date
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30/08/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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60 patients
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Interventions
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The study was double-blind and placebo-controlled. For ease of presentation the four subject groups are given the following descriptors:
Group 1: 30 mg FruitexB® twice per day
Group 2: 60 mg FruitexB® twice per day
Group 3: 120 mg FruitexB® twice per day
Group 4: 120 mg placebo twice per day. Placebo material was based on fructose only.
The duration of the treatment was 2 weeks, administered as 2 capsules twice per day (BID) ingested orally with meals. Survey on dietary intake was carried out by personal interview. Interviewers presented tableware and food models and investigated the meal intake on 2 different weekdays and 1 weekend day based on recall method. Nutrient intake was calculated by use of the DietSYS+Plus (version 5.9), dietary analysis program (Block Dietary Data Systems). The DietSYS+Plus database, a software that analyses nutrients, was expanded for the present study to include dietary boron values in foods consumed in Romania. After calculating the intake of nutrients per individual, percentage of the intake was calculated in relation to Dietary Reference Intakes for Romania. Subsequently, boron intake was calculated useing the boron content database of the foods commonly consumed by Romanian urban and rural people. We utilised the analytical B nutrient database that was previously developed for the purpose of estimating B intake.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
These were measured at the first visit in the day when study begun, and the next measure was done after 2 weeks.
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Sources of funding
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1. Natural Research, Ltd (Romania) - Research Project (ref: 12/2008)
2. University of Medicine and Pharmacy of Craiova (Romania)
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Trial website
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Publications
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Contact name
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Prof
Romulus
Scorei
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Address
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a.i.cuza no.13
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City/town
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Craiova
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Zip/Postcode
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200385
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Country
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Romania
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Tel
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+40 (0)251 41 59 60
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Fax
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+40 (0)251 41 59 60
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Email
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romulusscorei@gmail.com
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Sponsor
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Natural Research, Ltd (Romania)
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Address
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a.i.cuza no.13
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City/town
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Craiova
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Zip/Postcode
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200285
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Country
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Romania
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Tel
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+40 (0)251 41 59 60
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Fax
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+40 (0)251 41 59 60
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Email
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romulus_ion@yahoo.com
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Sponsor website:
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http://www.naturalresearch.ro/
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Date applied
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23/02/2010
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Last edited
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17/03/2010
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Date ISRCTN assigned
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17/03/2010
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