A Comparison of Changes in Bone Density With the Same Bone-health Plan, But With Different Bone-health Supplements - Full Text View

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 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

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Dietary Supplements Minerals

U.S. FDA Resources

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 ] [ 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.

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 ] [ 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.


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
Genders Eligible for Study:	Both
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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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

No publications provided by Integrative Health Technologies, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on March 03, 2015