A Comparison of Changes in Bone Density With the Same Bone-health Plan, But With Different Bone-health Supplements
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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|
- 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.
- 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.
|Study Start Date:||June 2006|
|Study Completion Date:||March 2010|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|