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
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | April 19, 2010 | ||||||||
| Last Updated Date | April 30, 2010 | ||||||||
| Start Date ICMJE | June 2006 | ||||||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Changes in Bone Mineral Density (BMD) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ] 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. |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01114685 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] 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. |
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Comparison of Changes in Bone Density With the Same Bone-health Plan, But With Different Bone-health Supplements | ||||||||
| Official Title ICMJE | Bone Mineral Density (BMD) Changes in a Bone Health Plan Using Two Versions of a Bone Health Supplement: A Comparative Effectiveness Research (CER) Study | ||||||||
| Brief Summary | A comparison of changes in bone density following the same bone-health plan, but with a different bone-health supplement. |
||||||||
| 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:
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. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
||||||||
| Condition ICMJE | Osteopenia | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Michalek JE, Preuss HG, Croft HA, Keith PL, Keith SC, Dapilmoto M, Perricone NV, Leckie RB, Kaats GR. Changes in total body bone mineral density following a common bone health plan with two versions of a unique bone health supplement: a comparative effectiveness research study. Nutr J. 2011 Apr 14;10:32. | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 354 | ||||||||
| Completion Date | March 2010 | ||||||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01114685 | ||||||||
| Other Study ID Numbers ICMJE | AlgaeCal 1 & 2 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Gilbert R. Kaats, PhD, Integrative Health Technologies, Inc. | ||||||||
| Study Sponsor ICMJE | Integrative Health Technologies, Inc. | ||||||||
| Collaborators ICMJE | AlgaeCal Inc. | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Integrative Health Technologies, Inc. | ||||||||
| Verification Date | April 2010 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||