Trial Outcomes & Findings for Effects of Naturally Silicon-Rich Water on Bone Metabolism in Women (NCT NCT01067508)
NCT ID: NCT01067508
Last Updated: 2019-07-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
12 Weeks
Results posted on
2019-07-23
Participant Flow
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.
Participant milestones
| Measure |
Fiji Water
Participants are asked to consume 1 liter of this silicon-rich water daily for 12 weeks.
|
Aquafina Water
Participants are asked to drink 1 liter of this deionized water daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Fiji Water
Participants are asked to consume 1 liter of this silicon-rich water daily for 12 weeks.
|
Aquafina Water
Participants are asked to drink 1 liter of this deionized water daily for 12 weeks.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Effects of Naturally Silicon-Rich Water on Bone Metabolism in Women
Baseline characteristics by cohort
| Measure |
Fiji Water
n=10 Participants
Participants are asked to consume 1 liter of this silicon-rich water (Fiji) daily for 12 weeks.
|
Aquafina Water
n=9 Participants
Participants are asked to drink 1 liter of this deionized water daily for 12 weeks.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
53.75 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksChange 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.
Outcome measures
| Measure |
Aquafina Water
n=9 Participants
Participants are asked to drink 1 liter of this deionized water daily for 12 weeks.
|
Fiji Water
n=10 Participants
Participants are asked to drink 1 liter of this silicon-rich water daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Silicon Absorption at 12 Weeks
baseline silicon
|
0.010 mg/mg creatinine
Standard Deviation 0.004
|
0.016 mg/mg creatinine
Standard Deviation 0.01
|
|
Change From Baseline in Silicon Absorption at 12 Weeks
12 week silicon
|
0.009 mg/mg creatinine
Standard Deviation 0.006
|
0.037 mg/mg creatinine
Standard Deviation 0.014
|
Adverse Events
Fiji Water
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aquafina Water
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fiji Water
n=10 participants at risk
Participants are asked to consume 1 liter of this silicon-rich water (Fiji) daily for three months.
|
Aquafina Water
n=9 participants at risk
Participants are asked to drink 1 liter of this deionized water daily for 12 weeks.
|
|---|---|---|
|
Cardiac disorders
Cardiovascular Health
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place