A Comparison of Changes in Bone Density With the Same Bone-health Plan, But With Different Bone-health Supplements
Bone Mineral Density (BMD) Changes in a Bone Health Plan Using Two Versions of a Bone Health Supplement: A Comparative Effectiveness Research (CER) Study
1 other identifier
interventional
354
1 country
1
Brief Summary
A comparison of changes in bone density following the same bone-health plan, but with a different bone-health supplement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 19, 2010
CompletedFirst Posted
Study publicly available on registry
May 3, 2010
CompletedMay 3, 2010
April 1, 2010
2.1 years
April 19, 2010
April 30, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in Bone Mineral Density (BMD)
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.
baseline and 6 months
Secondary Outcomes (1)
A comparison of changes from baseline in 43-blood chemistry panel and a self-reported quality of life inventory in both study groups
six months
Study Arms (2)
Effects of taking AlgaeCal-1
ACTIVE COMPARATORFollowing a bone health plan with Algae-cal-1 supplement
Effects of taking AlgaeCal-2
ACTIVE COMPARATORFollowing a bone-health plan while consuming AlgaeCal 2
Interventions
Daily consumption of 7 capsules containing bone health ingredients
Eligibility Criteria
You may qualify if:
- All subjects were required to contact the physicians to ensure they had no medical issues that would preclude their participation.
You may not qualify if:
- Younger the 18 years of age, and
- Recommendations not to participate from their physicians.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Integrative Health Technologies, Inc.lead
- AlgaeCal Inc.collaborator
Study Sites (1)
Integrative Health Technologies
San Antonio, Texas, 78209, United States
Related Publications (1)
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. doi: 10.1186/1475-2891-10-32.
PMID: 21492428DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gilbert R Kaats, PhD
Integrative Health Technologies
- PRINCIPAL INVESTIGATOR
Harry G Preuss, MD
Georgetown University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
April 19, 2010
First Posted
May 3, 2010
Study Start
June 1, 2006
Primary Completion
July 1, 2008
Study Completion
March 1, 2010
Last Updated
May 3, 2010
Record last verified: 2010-04