Bone Diseases, MetabolicNCT01067508
Effects of Naturally Silicon-Rich Water on Bone Metabolism in Women
A study testing Fiji Water in people with Bone Diseases, Metabolic, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The aim of this research study is to determine by laboratory analyses the effects of drinking silicon-rich water on bone health. This will be determined from blood and urine samples from subjects who will be asked to drink 1 liter per day of either silicon-rich water or water without silicon for 12 weeks. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Diseases, Metabolic
- What is being tested?
- Fiji Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Feb 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Body mass index (BMI) < 30
- Postmenopausal women with no evidence of osteoporosis by dual energy X-ray absorptiometry (DEXA) scan (T ≥ -2 in the total hip and lumbar spine).
- Pre- or peri-menopausal women with osteopenia but no evidence of osteoporosis by DEXA scan (-1.5 ≤ T ≤ -2 in the total hip and lumbar spine)
- No estrogens or corticosteroids
- No prior history of bisphosphonate medication
- Otherwise in good health with no significant illnesses which could affect bone metabolism such as hypercortisolism, untreated hypothyroidism, treatment with statins or other drugs affecting bone metabolism other than calcium and vitamin D3.
- No change in exercise regimen or calcium intake in the past 3 months.
- Subject must sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or randomization. A subject will be excluded for any condition that might compromise the ability to give truly informed consent for participation in the study.
Who cannot join
- Males
- Premenopausal women with DEXA T scores ≥ -1.5 or ≤ -2.
- Postmenopausal women with DEXA T scores ≤ -2.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Effects of Naturally Occurring Silicon in Drinking Water on Bone Metabolism
The aim of this research study is to determine by laboratory analyses the effects of drinking silicon-rich water on bone health. This will be determined from blood and urine samples from subjects who will be asked to drink 1 liter per day of either silicon-rich water or water without silicon for 12 weeks.
Read the detailed description
Naturally occurring silicon as aqueous silicic acids at a level of 85 mg/liter which is well within safe intake limits occurs in water obtained from artesian wells in Fiji (Fiji Water, Inc.). Other drinking waters (e.g. Aquafina, Crystal Geyser, etc.) have all trace minerals including silicon removed by reverse osmosis. Silicon may be a necessary mineral for bone health. Therefore, this study aims to demonstrate the potential beneficial effects of short-term intake of silicon-rich water (85 mg/day of silicon in the diet from 1 liter of Fiji Water) compared to deionized water (with no silicon) over 12 weeks in normal postmenopausal women. The women to be studied will be stratified by bone density (based on T score by DEXA) and have analyses of biomarkers of bone metabolism to achieve the following specific aims:
- To conduct a prospective randomized controlled trial in two mixed groups of 15 normal postmenopausal women and osteopenic pre- and peri-menopausal women receiving either 1 liter per day of FIJI water (A) or 1 liter per day of purified drinking water with no minerals (B). During screening we will ask prospective participants about their menopausal status (where post-menopausal means having no menstrual period for one year), block on their menopausal status, and randomize to either Treatment A or Treatment B. There will be 7-8 post-menopausal women and 7-8 pre- or peri-menopausal women in each group.
- To determine silicon absorption by measuring urinary silicon excretion
- To determine bone resorption and turn over markers by measuring urinary N-Telopeptide, serum bone alkaline phosphatase, osteocalcin, procollagen Type I Intact N-Terminal Propeptide, 25 hydroxyvitamin D, parathyroid hormone (PTH) and calcium.
- Conditions
- Bone Diseases, Metabolic
- Being tested
- Fiji Water
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiji WaterOther
Participants are asked to drink one liter of this silicon-rich water daily for three months.
| Study group | Role | What they receive |
|---|---|---|
| Fiji Water | Experimental | Participants are asked to consume one liter of this silicon-rich water daily for three months. Receives: Other: Fiji Water |
| Aquafina Water | No intervention | Participants are asked to drink one liter of this deionized water daily for three months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Silicon Absorption at 12 Weeks
Change from baseline in silicon absorption in response to silicon-rich water (Fiji) supplementation for 12 weeks was determined by measuring urinary solicon concentration (mg/mg) normalized to creatinine.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startJun 2007
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone Diseases, MetabolicStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- David Heber, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067508
- Sponsor's protocol ID
- 06-12-097-03
- Status last verified
- May 2019
- First submitted
- 8 Feb 2010
- Last updated
- 23 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Li Z, Karp H, Zerlin A, Lee TY, Carpenter C, Heber D. Absorption of silicon from artesian aquifer water and its impact on bone health in postmenopausal women: a 12 week pilot study. Nutr J. 2010 Oct 14;9:44. doi: 10.1186/1475-2891-9-44.
PubMed 20946656
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Naturally Occurring Silicon in Drinking Water on Bone Metabolism
- ClinicalTrials.gov ID
- NCT01067508
- Acronym / sponsor ID
- 06-12-097-03
- Conditions
- Bone Diseases, Metabolic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Feb 2010 (estimated)
- Results
- Posted 23 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this research study is to determine by laboratory analyses the effects of drinking silicon-rich water on bone health. This will be determined from blood and urine samples from subjects who will be asked to drink 1 liter per day of either silicon-rich water or water without silicon for 12 weeks.
Detailed description
Naturally occurring silicon as aqueous silicic acids at a level of 85 mg/liter which is well within safe intake limits occurs in water obtained from artesian wells in Fiji (Fiji Water, Inc.). Other drinking waters (e.g. Aquafina, Crystal Geyser, etc.) have all trace minerals including silicon removed by reverse osmosis. Silicon may be a necessary mineral for bone health. Therefore, this study aims to demonstrate the potential beneficial effects of short-term intake of silicon-rich water (85 mg/day of silicon in the diet from 1 liter of Fiji Water) compared to deionized water (with no silicon) over 12 weeks in normal postmenopausal women. The women to be studied will be stratified by bone density (based on T score by DEXA) and have analyses of biomarkers of bone metabolism to achieve the following specific aims:
- To conduct a prospective randomized controlled trial in two mixed groups of 15 normal postmenopausal women and osteopenic pre- and peri-menopausal women receiving either 1 liter per day of FIJI water (A) or 1 liter per day of purified drinking water with no minerals (B). During screening we will ask prospective participants about their menopausal status (where post-menopausal means having no menstrual period for one year), block on their menopausal status, and randomize to either Treatment A or Treatment B. There will be 7-8 post-menopausal women and 7-8 pre- or peri-menopausal women in each group.
- To determine silicon absorption by measuring urinary silicon excretion
- To determine bone resorption and turn over markers by measuring urinary N-Telopeptide, serum bone alkaline phosphatase, osteocalcin, procollagen Type I Intact N-Terminal Propeptide, 25 hydroxyvitamin D, parathyroid hormone (PTH) and calcium.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiji Water | Experimental | Other: Fiji WaterParticipants are asked to consume one liter of this silicon-rich water daily for three months. |
| Aquafina Water | No intervention | –Participants are asked to drink one liter of this deionized water daily for three months. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Body mass index (BMI) < 30
- Postmenopausal women with no evidence of osteoporosis by dual energy X-ray absorptiometry (DEXA) scan (T ≥ -2 in the total hip and lumbar spine).
- Pre- or peri-menopausal women with osteopenia but no evidence of osteoporosis by DEXA scan (-1.5 ≤ T ≤ -2 in the total hip and lumbar spine)
- No estrogens or corticosteroids
- No prior history of bisphosphonate medication
Key exclusion criteria (3 listed)
- Males
- Premenopausal women with DEXA T scores ≥ -1.5 or ≤ -2.
- Postmenopausal women with DEXA T scores ≤ -2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fiji WaterParticipants are asked to drink one liter of this silicon-rich water daily for three months. | Other | Fiji Water |
Primary outcome
Change From Baseline in Silicon Absorption at 12 Weeks
Time frame: 12 Weeks
Change from baseline in silicon absorption in response to silicon-rich water (Fiji) supplementation for 12 weeks was determined by measuring urinary solicon concentration (mg/mg) normalized to creatinine.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20946656Li Z, Karp H, Zerlin A, Lee TY, Carpenter C, Heber D. Absorption of silicon from artesian aquifer water and its impact on bone health in postmenopausal women: a 12 week pilot study. Nutr J. 2010 Oct 14;9:44. doi: 10.1186/1475-2891-9-44.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Heber, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiji Water in people with Bone Diseases, Metabolic, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Silicon Absorption at 12 Weeks (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01067508, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.