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:

ClinicalTrials.gov Identifier:

NCT01114685

First Posted: May 3, 2010

Last Update Posted: May 3, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

AlgaeCal Inc.

Information provided by:

Integrative Health Technologies, Inc.

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 Intervention Model: Parallel Assignment Masking: None (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 ]
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 ]
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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

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

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

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
First Submitted:	April 19, 2010
First Posted:	May 3, 2010
Last Update Posted:	May 3, 2010
Last Verified:	April 2010

Additional relevant MeSH terms:


Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases

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