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

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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:
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE February 8, 2010
First Posted Date  ICMJE February 11, 2010
Results First Submitted Date  ICMJE October 6, 2016
Results First Posted Date  ICMJE July 23, 2019
Last Update Posted Date July 23, 2019
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: 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  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 ]
Change History Complete list of historical versions of study NCT01067508 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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

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  ICMJE Interventional
Study Phase  ICMJE 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  ICMJE
  • 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 15, 2019)
19
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2010)
30
Actual Study Completion Date  ICMJE 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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE 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 No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP