Effects of Naturally Silicon-Rich Water on Bone Metabolism in Women

Tracking Information
First Submitted Date ICMJE	February 8, 2010
First Posted Date ICMJE	February 11, 2010
Last Update Posted Date	May 13, 2013
Study Start Date ICMJE	June 2007
Actual Primary Completion Date	December 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 10, 2010)	To measure changes in 12 weeks of biomarkers of bone formation and bone resorption, blood levels of 25 hydroxyvitamin D, parathyroid hormone (PTH), calcium, and urinary silicon. [ Time Frame: 12 Weeks ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01067508 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 2, 2010)	To assess whether the silicon in Fiji water increases bone formation parameters and/or reduces the bone resorption parameter, thus suggesting a benefit in bone health. [ Time Frame: 12 Weeks ]
Original Secondary Outcome Measures ICMJE; (submitted: February 10, 2010)	To assess whether the silicon in Fiji water increases bone formation parameters and/or reduces the bone resorption parameter, thus suggesting a benefit in bone health. [ Time Frame: Post-study analysis ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effects of Naturally Silicon-Rich Water on Bone Metabolism in Women
Official Title ICMJE	Effects of Naturally Occurring Silicon in Drinking Water on Bone Metabolism
Brief 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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
Condition ICMJE	Bone Diseases, Metabolic
Intervention ICMJE	Other: Fiji Water; Participants are asked to drink one liter of this silicon-rich water daily for three months.
Study Arms	Experimental: Fiji Water Participants are asked to consume one liter of this silicon-rich water daily for three months. Intervention: Other: Fiji Water; No Intervention: Aquafina Water Participants are asked to drink one liter of this deionized water daily for three months.
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 8, 2013)	15
Original Estimated Enrollment ICMJE; (submitted: February 10, 2010)	30
Actual Study Completion Date	February 2011
Actual Primary Completion Date	December 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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. Exclusion Criteria: Males; Premenopausal women with DEXA T scores ≥ -1.5 or ≤ -2.; Postmenopausal women with DEXA T scores ≤ -2.
Sex/Gender	Sexes Eligible for Study: Female
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01067508
Other Study ID Numbers ICMJE	06-12-097-03
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Zhaoping Li, University of California, Los Angeles
Study Sponsor ICMJE	University of California, Los Angeles
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: David Heber, MD, PhD University of California, Los Angeles
PRS Account	University of California, Los Angeles
Verification Date	May 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP