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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

February 8, 2010
May 8, 2013
June 2007
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01067508 on ClinicalTrials.gov Archive Site
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 ]
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effects of Naturally Silicon-Rich Water on Bone Metabolism in Women
Effects of Naturally Occurring Silicon in Drinking Water on Bone Metabolism

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Bone Diseases, Metabolic
Other: Fiji Water
Participants are asked to drink one liter of this silicon-rich water daily for three months.
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
February 2011
December 2010   (final data collection date for primary outcome measure)

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.
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01067508
06-12-097-03
Not Provided
Zhaoping Li, University of California, Los Angeles
University of California, Los Angeles
Not Provided
Principal Investigator: David Heber, MD, PhD University of California, Los Angeles
University of California, Los Angeles
May 2013

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