Calcium fructoborate effect on systemic inflammation and dyslipidaemia markers in middle-aged people with primary osteoarthritis
| ISRCTN | ISRCTN46679573 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46679573 |
| Secondary identifying numbers | Research Project no.12/2008 |
- Submission date
- 23/02/2010
- Registration date
- 17/03/2010
- Last edited
- 29/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Romulus Scorei
Scientific
Scientific
a.i.cuza no.13
Craiova
200385
Romania
| Phone | +40 (0)251 41 59 60 |
|---|---|
| romulusscorei@gmail.com |
Study information
| Study design | Randomised double-blind placebo-controlled single centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | FruiteB |
| Study hypothesis | 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. |
| Ethics approval(s) | 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. |
| Condition | Primary osteoarthritis |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | FruitexB® (calcium fructoborate) |
| Primary outcome measure | 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 | 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. |
| Overall study start date | 10/03/2008 |
| Overall study end date | 30/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 patients |
| Total final enrolment | 72 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 10/03/2008 |
| Recruitment end date | 30/08/2009 |
Locations
Countries of recruitment
- Romania
Study participating centre
a.i.cuza no.13
Craiova
200385
Romania
200385
Romania
Sponsor information
Natural Research, Ltd (Romania)
Industry
Industry
a.i.cuza no.13
Craiova
200285
Romania
| Phone | +40 (0)251 41 59 60 |
|---|---|
| romulus_ion@yahoo.com | |
| Website | http://www.naturalresearch.ro/ |
Funders
Funder type
Industry
Natural Research, Ltd (Romania) - Research Project (ref: 12/2008)
No information available
University of Medicine and Pharmacy of Craiova (Romania)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2011 | 29/12/2020 | Yes | No |
Editorial Notes
29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
