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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01067508
First Posted: February 11, 2010
Last Update Posted: May 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles
  Purpose
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.

Condition Intervention
Bone Diseases, Metabolic Other: Fiji Water

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Naturally Occurring Silicon in Drinking Water on Bone Metabolism

Resource links provided by NLM:


Further study details as provided by Zhaoping Li, University of California, Los Angeles:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: June 2007
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fiji Water
Participants are asked to consume one liter of this silicon-rich water daily for three months.
Other: Fiji Water
Participants are asked to drink one liter of this silicon-rich water daily for three months.
No Intervention: Aquafina Water
Participants are asked to drink one liter of this deionized water daily for three months.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067508


Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: David Heber, MD, PhD University of California, Los Angeles
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zhaoping Li, Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01067508     History of Changes
Other Study ID Numbers: 06-12-097-03
First Submitted: February 8, 2010
First Posted: February 11, 2010
Last Update Posted: May 13, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Bone Diseases
Metabolic Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Silicon
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs