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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 8, 2010

Last Updated Date

May 8, 2013

Start Date ^ICMJE

June 2007

Primary Completion Date

December 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01067508 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

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

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

Enrollment ^ICMJE

Completion Date

February 2011

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

Sexes Eligible for Study:

Female

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

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

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

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 2013

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

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