search
Back to results

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

Primary Purpose

Bone Diseases, Metabolic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fiji Water
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bone Diseases, Metabolic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California, Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fiji Water

Aquafina Water

Arm Description

Participants are asked to consume one liter of this silicon-rich water daily for three months.

Participants are asked to drink one liter of this deionized water daily for three months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2010
Last Updated
May 15, 2019
Sponsor
University of California, Los Angeles
search

1. Study Identification

Unique Protocol Identification Number
NCT01067508
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Diseases, Metabolic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fiji Water
Arm Type
Experimental
Arm Description
Participants are asked to consume one liter of this silicon-rich water daily for three months.
Arm Title
Aquafina Water
Arm Type
No Intervention
Arm Description
Participants are asked to drink one liter of this deionized water daily for three months.
Intervention Type
Other
Intervention Name(s)
Fiji Water
Intervention Description
Participants are asked to drink one liter of this silicon-rich water daily for three months.
Primary Outcome Measure Information:
Title
Change From Baseline in Silicon Absorption at 12 Weeks
Description
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.
Time Frame
12 Weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Heber, MD, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20946656
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs