Effect on bone turnover and Bone Mineral Density (BMD) of low dose oral silicon as an adjunct to calcium/vitamin D3 in a randomised, placebo-controlled trial
| ISRCTN | ISRCTN57103074 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57103074 |
| Secondary identifying numbers | n° 00/1 |
- Submission date
- 05/12/2007
- Registration date
- 07/01/2008
- Last edited
- 04/07/2011
- 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 of protocol
Not provided at time of registration
Contact information
Prof Tim Spector
Scientific
Scientific
Twin Research and Genetic Epidemiology Unit
St Thomas' Hospital
Kings College
London
SE1 7EH
United Kingdom
Study information
| Study design | Double blind, placebo controlled randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Effect on bone turnover and Bone Mineral Density (BMD) of low dose oral silicon as an adjunct to calcium/vitamin D3 in a randomised, placebo-controlled trial |
| Study objectives | To investigate the effect of low dose oral silicon as an adjunct to calcium/vitamin D3 on markers of bone turnover and BMD. |
| Ethics approval(s) | Ethics approval received from St Thomas Hospital Local Research Ethics Committee on the 20th March 2001 (ref: EC01/009). |
| Health condition(s) or problem(s) studied | Osteopenia |
| Intervention | Subjects who meet the inclusion and exclusion criteria were randomly assigned to four groups to take by oral route choline-stabilized Orthosilicic Acid (ch-OSA) or a placebo daily for 12 months. Three different ch-OSA doses (3, 6 and 12 drops) were used corresponding to 3, 6, and 12 mg Si. The placebo group was divided in 3 subgroups (3, 6, and 12 drops) to mimic the three different ch-OSA dosages. The study medication was delivered in sealed 30 ml plastic bottles. The subjects were instructed to mix the ch-OSA or placebo drops with 50 ml (2 floz, 1/4 glass) water or juice and to consume immediately, preferably 30 minutes before a meal or 2 hours after a meal. All subjects received calcium and vitamin D3 (Calcichew/D3 forte, Shire, UK) containing 1000 mg calcium and 20 mg cholecalciferol daily. A basic clinical examination was performed at each visit. Blood samples and single void urine samples were collected from fasting subjects at baseline and after 12 months supplementation to evaluate the safety parameters. Bone Mineral Density (BMD) was assessed by DEXA using a Hologic QDR 4500 W (Waltham, MA). Scans of the lumbar spine (L1 to L4) and femur (neck, trochanter, intertrochanteric area, Wards triangle and total) were performed at screening and/or at the inclusion visit and then after 12 months treatment at the final visit. Biochemical markers of bone formation (Osteocalcin [OC], Bone-specific Alkaline Phosphatase [BAP], Procollagen type I N-terminal Propeptide [PINP]) and bone resorption (Deoxypyridoline [DPD], C-terminal telopeptide of type I collagen [CTX-I]) were measured at baseline and after 6 and 12 months of treatment. |
| Intervention type | Supplement |
| Primary outcome measure | 1. The effect of oral ch-OSA on BMD, measured at baseline and after 12 months 2. The effect of oral ch-OSA on markers of bone turnover, measured at baseline and after 6 and 12 months of treatment |
| Secondary outcome measures | 1. Ch-OSA related adverse events, measured at baseline and after 12 months treatment 2. Biochemical safety parameters of oral use of ch-OSA, measured at baseline and after 12 months treatment |
| Overall study start date | 01/06/2001 |
| Completion date | 01/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Female |
| Target number of participants | 184 |
| Key inclusion criteria | 1. Osteopenic, but otherwise healthy 2. Caucasian women with a T-score less than -1.5 at the lumbar spine by Dual Energy X-ray Absorptiometry (DEXA) scan 3. Age range: mean age of 60.7 ± 10.4 years; gender of participants: female |
| Key exclusion criteria | Patients were excluded according to the following criteria: 1. Renal failure as defined by serum creatinine greater than 200 µmol/L 2. Abnormal serum ferritin level (normal range: 11 - 250 µg/L) 3. Concomitant medication (treatment with phosphate-binding antacids greater than 6 months/year) 4. Oral glucocorticoid treatment (greater than 8 months in the previous year and greater than 7.5 mg/day prednisone equivalent, or a total dose of more than 2 g prednisone equivalent in the previous 12 months) 5. Local injectable glucocorticoid treatment if greater than 5 injections per year 6. Inhaled glucocorticoid treatment if greater than 6 months in the previous year and more than 2 mg/day prednisone equivalent (glucocorticoids by local topical administration were not excluded) 7. Concomitant or previous treatment for bone diseases: 7.1. Fluoride salts: greater than 10 mg/day, for more than 2 weeks in the previous 12 months 7.2. Biphosphanates: for more than 2 weeks in the previous 12 months 7.3. Oral estrogens 7.4. Estradiol vaginal ring 7.5. Anti-estrogens 7.6. Progesterones 7.7. Anabolic steroids in the previous 3 months or used for more than 1 month in the previous 6 months 7.8. Estradiol implants in the previous 3 years 7.9. Ipriflavone use in the previous 6 months or used for more than 1 month in the previous 12 months 7.10. Calcitonin use in the previous month or used for more than 1 month in the previous 6 months 8. Other drugs for bone disease currently in development 9. Concomitant and previous use of food supplements containing silicon or horsetail herb extract, bamboo extract, colloidal silicic acid, or silanol derivatives in the previous 6 months |
| Date of first enrolment | 01/06/2001 |
| Date of final enrolment | 01/02/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Twin Research and Genetic Epidemiology Unit
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Bio Minerals N.V. (Belgium)
Industry
Industry
Zenderstraat 12
Destelbergen
9070
Belgium
Funders
Funder type
Charity
National Osteoporosis Society (UK)
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- NOS
- Location
- United Kingdom
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 | 11/06/2008 | Yes | No |
