N/A
Completed N=19
Effects of Naturally Silicon-Rich Water on Bone Metabolism in Women
Bone Diseases, Metabolic
Source: ClinicalTrials.gov NCT01067508 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Change From Baseline in Silicon Absorption at 12 Weeks — 0.010; 0.016; 0.009; 0.037 mg/mg creatinine — p=0.003
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Silicon Absorption at 12 Weeks |
0.010; 0.016; 0.009; 0.037 | 0.003 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01067508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.