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

Bone Diseases, Metabolic Clinical Trial

Official title:

Effects of Naturally Occurring Silicon in Drinking Water on Bone Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067508
• Other study ID #: 06-12-097-03
• Status: Completed
• Phase: N/A
• Start date: June 2007
• Est. completion date: February 2011

Study information

• Verified date: May 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Naturally occurring silicon as aqueous silicic acids at a level of 85 mg/liter which is well within safe intake limits occurs in water obtained from artesian wells in Fiji (Fiji Water, Inc.). Other drinking waters (e.g. Aquafina, Crystal Geyser, etc.) have all trace minerals including silicon removed by reverse osmosis. Silicon may be a necessary mineral for bone health. Therefore, this study aims to demonstrate the potential beneficial effects of short-term intake of silicon-rich water (85 mg/day of silicon in the diet from 1 liter of Fiji Water) compared to deionized water (with no silicon) over 12 weeks in normal postmenopausal women. The women to be studied will be stratified by bone density (based on T score by DEXA) and have analyses of biomarkers of bone metabolism to achieve the following specific aims:

1. To conduct a prospective randomized controlled trial in two mixed groups of 15 normal postmenopausal women and osteopenic pre- and peri-menopausal women receiving either 1 liter per day of FIJI water (A) or 1 liter per day of purified drinking water with no minerals (B). During screening we will ask prospective participants about their menopausal status (where post-menopausal means having no menstrual period for one year), block on their menopausal status, and randomize to either Treatment A or Treatment B. There will be 7-8 post-menopausal women and 7-8 pre- or peri-menopausal women in each group.

2. To determine silicon absorption by measuring urinary silicon excretion

3. To determine bone resorption and turn over markers by measuring urinary N-Telopeptide, serum bone alkaline phosphatase, osteocalcin, procollagen Type I Intact N-Terminal Propeptide, 25 hydroxyvitamin D, parathyroid hormone (PTH) and calcium.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Metabolic Diseases

Intervention

Other:
• Fiji Water
Participants are asked to drink one liter of this silicon-rich water daily for three months.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Silicon Absorption at 12 Weeks	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.	12 Weeks