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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:
Collaborator:
AlgaeCal Inc.
Information provided by:
Integrative Health Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01114685
First received: April 19, 2010
Last updated: April 30, 2010
Last verified: April 2010
History of Changes
  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:

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:

  1. improve nutrition,
  2. increase health literacy and,
  3. 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
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):

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

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 16, 2013