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

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.
 
ClinicalTrials.gov Identifier: NCT01067508
Recruitment Status : Completed
First Posted : February 11, 2010
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Bone Diseases, Metabolic
Intervention Other: Fiji Water
Enrollment 19
Recruitment Details Subjects will be recruited by posting flyers around the UCLA campus community. Initial eligibility will be determined by a telephone conversation in which the study procedures and inclusion/exclusion criteria are reviewed.
Pre-assignment Details  
Arm/Group Title Fiji Water Aquafina Water
Hide Arm/Group Description Participants are asked to consume 1 liter of this silicon-rich water daily for 12 weeks. Participants are asked to drink 1 liter of this deionized water daily for 12 weeks.
Period Title: Overall Study
Started 10 9
Completed 10 7
Not Completed 0 2
Reason Not Completed
Physician Decision             0             1
Withdrawal by Subject             0             1
Arm/Group Title Fiji Water Aquafina Water Total
Hide Arm/Group Description Participants are asked to consume 1 liter of this silicon-rich water (Fiji) daily for 12 weeks. Participants are asked to drink 1 liter of this deionized water daily for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 10 9 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 9 participants 19 participants
53.1  (6.5) 54.4  (3.9) 53.75  (5.2)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Female Number Analyzed 10 participants 9 participants 19 participants
10
 100.0%
9
 100.0%
19
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
3
  33.3%
3
  15.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  20.0%
2
  22.2%
4
  21.1%
White
8
  80.0%
4
  44.4%
12
  63.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants 9 participants 19 participants
10
 100.0%
9
 100.0%
19
 100.0%
1.Primary Outcome
Title Change From Baseline in Silicon Absorption at 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aquafina Water Fiji Water
Hide Arm/Group Description:
Participants are asked to drink 1 liter of this deionized water daily for 12 weeks.
Participants are asked to drink 1 liter of this silicon-rich water daily for 12 weeks.
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: mg/mg creatinine
baseline silicon 0.010  (0.004) 0.016  (0.01)
12 week silicon 0.009  (0.006) 0.037  (0.014)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fiji Water
Comments Comparison was made to 12 weeks minus baseline change in Fiji water group
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments p<0.05 was defined as significant
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aquafina Water
Comments Comparison was made to the 12 week minus baseline change in Aquafina (control) group
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments p<0.05 was defined as significant
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fiji Water Aquafina Water
Hide Arm/Group Description Participants are asked to consume 1 liter of this silicon-rich water (Fiji) daily for three months. Participants are asked to drink 1 liter of this deionized water daily for 12 weeks.
All-Cause Mortality
Fiji Water Aquafina Water
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Fiji Water Aquafina Water
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/9 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.0%
Fiji Water Aquafina Water
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      1/9 (11.11%)    
Cardiac disorders     
Cardiovascular Health * [1]  0/10 (0.00%)  0 1/9 (11.11%)  1
*
Indicates events were collected by non-systematic assessment
[1]
One subject was withdrawn by the investigator concerning her cardiovascular health (not specified).
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Zhaoping Li
Organization: UCLA Center for Human Nutrition
Phone: 310-206-1987
EMail: zli@mednet.ucla.edu
Layout table for additonal information
Responsible Party: Zhaoping Li, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01067508    
Other Study ID Numbers: 06-12-097-03
First Submitted: February 8, 2010
First Posted: February 11, 2010
Results First Submitted: October 6, 2016
Results First Posted: July 23, 2019
Last Update Posted: July 23, 2019