A Comparison of Changes in Bone Density With the Same Bone-health Plan, But With Different Bone-health Supplements
|ClinicalTrials.gov Identifier: NCT01114685|
Recruitment Status : Completed
First Posted : May 3, 2010
Last Update Posted : May 3, 2010
|Condition or disease||Intervention/treatment||Phase|
|Osteopenia||Dietary Supplement: AlgaeCal-1 Dietary Supplement: AlgaeCal-2||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||354 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||March 2010|
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01114685
|United States, Texas|
|Integrative Health Technologies|
|San Antonio, Texas, United States, 78209|
|Principal Investigator:||Gilbert R Kaats, PhD||Integrative Health Technologies|
|Principal Investigator:||Harry G Preuss, MD||Georgetown University|