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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01067508
First received: February 8, 2010
Last updated: May 8, 2013
Last verified: May 2013
  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: 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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of California, Los Angeles

Additional 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
Study First Received: February 8, 2010
Last Updated: May 8, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 28, 2014