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A Comparison of Changes in Bone Density With the Same Bone-health Plan, But With Different Bone-health Supplements
This study has been completed.
Sponsor:
Integrative Health Technologies, Inc.
Collaborator:
AlgaeCal Inc.
Information provided by:
Integrative Health Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01114685
First received: April 19, 2010
Last updated: April 30, 2010
Last verified: April 2010
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Purpose
A comparison of changes in bone density following the same bone-health plan, but with a different bone-health supplement.
| Condition | Intervention |
|---|---|
| Osteopenia | Dietary Supplement: AlgaeCal-1 Dietary Supplement: AlgaeCal-2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
| Official Title: | Bone Mineral Density (BMD) Changes in a Bone Health Plan Using Two Versions of a Bone Health Supplement: A Comparative Effectiveness Research (CER) Study |
Resource links provided by NLM:
Further study details as provided by Integrative Health Technologies, Inc.:
Primary Outcome Measures:
- Changes in Bone Mineral Density (BMD) [ Time Frame: baseline and 6 months ]Measurements of bone mineral density were conducted at baseline and 6 months from baseline in two different study groups following the same bone-health behavior modification plan, but with different versions of a bone-health calcium supplement.
Secondary Outcome Measures:
- A comparison of changes from baseline in 43-blood chemistry panel and a self-reported quality of life inventory in both study groups [ Time Frame: six months ]Study subjects in both arms of the study completed a fasting 43-blood chemistry panel and an 84-item self-reported quality of life inventory at baseline and again after participating in the study for six months. No significant differences were found in the within-group changes from baseline or between the groups on both sets of measures.
| Enrollment: | 354 |
| Study Start Date: | June 2006 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Effects of taking AlgaeCal-1
Following a bone health plan with Algae-cal-1 supplement
|
Dietary Supplement: AlgaeCal-1
Daily consumption of 7 capsules containing bone health ingredients
|
|
Active Comparator: Effects of taking AlgaeCal-2
Following a bone-health plan while consuming AlgaeCal 2
|
Dietary Supplement: AlgaeCal-2
Taking 7 capsules a day for six months
|
Detailed Description:
The US Surgeon General's Report on Bone Health suggests America's bone-health is in jeopardy and issued a "call to action" to develop bone-health plans that:
- improve nutrition,
- increase health literacy and,
- increase physical activity.
The purpose of this study was to use a comparative effective research model to compare 6-month changes in bone mineral density (BMD)in two study groups. Both followed the same bone health plan that contained the three components listed above with the same plant-source calcium supplement, but enhanced with different levels of calcium, vitamin D3, vitamin K and magnesium.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- All subjects were required to contact the physicians to ensure they had no medical issues that would preclude their participation.
Exclusion Criteria:
- Younger the 18 years of age, and
- Recommendations not to participate from their physicians.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01114685
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114685
Locations
| United States, Texas | |
| Integrative Health Technologies | |
| San Antonio, Texas, United States, 78209 | |
Sponsors and Collaborators
Integrative Health Technologies, Inc.
AlgaeCal Inc.
Investigators
| Principal Investigator: | Gilbert R Kaats, PhD | Integrative Health Technologies |
| Principal Investigator: | Harry G Preuss, MD | Georgetown University |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gilbert R. Kaats, PhD, Integrative Health Technologies, Inc. |
| ClinicalTrials.gov Identifier: | NCT01114685 History of Changes |
| Other Study ID Numbers: |
AlgaeCal 1 & 2 |
| Study First Received: | April 19, 2010 |
| Last Updated: | April 30, 2010 |
Additional relevant MeSH terms:
|
Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on September 19, 2017