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

• ClinicalTrials.gov Identifier: NCT01067508
• Recruitment Status: Completed
• First Posted: February 11, 2010
• Results First Posted: July 23, 2019
• Last Update Posted: July 23, 2019
• Sponsor: University of California, Los Angeles
• Information provided by (Responsible Party): Zhaoping Li, University of California, Los Angeles

Tracking Information

• First Submitted Date: February 8, 2010
• First Posted Date: February 11, 2010
• Results First Submitted Date: October 6, 2016
• Results First Posted Date: July 23, 2019
• Last Update Posted Date: July 23, 2019
• Study Start Date: June 2007
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 15, 2019)

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.

• Original Primary Outcome Measures (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 ]
• Change History: Complete list of historical versions of study NCT01067508 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (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 Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Naturally Silicon-Rich Water on Bone Metabolism in Women
• Official Title: 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

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:

1. 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.
2. To determine silicon absorption by measuring urinary silicon excretion
3. 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Bone Diseases, Metabolic

Intervention

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 15, 2019): 19
• Original Estimated Enrollment (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

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, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01067508
• Other Study ID Numbers: 06-12-097-03
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Zhaoping Li, University of California, Los Angeles
• Study Sponsor: University of California, Los Angeles
• Collaborators: Not Provided

Investigators

• Principal Investigator: David Heber, MD, PhD; University of California, Los Angeles

• PRS Account: University of California, Los Angeles
• Verification Date: May 2019