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

April 19, 2010
April 30, 2010
June 2006
July 2008   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01114685 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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

A comparison of changes in bone density following the same bone-health plan, but with a different bone-health supplement.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Osteopenia
  • Dietary Supplement: AlgaeCal-1
    Daily consumption of 7 capsules containing bone health ingredients
  • Dietary Supplement: AlgaeCal-2
    Taking 7 capsules a day for six months
  • Active Comparator: Effects of taking AlgaeCal-1
    Following a bone health plan with Algae-cal-1 supplement
    Intervention: Dietary Supplement: AlgaeCal-1
  • Active Comparator: Effects of taking AlgaeCal-2
    Following a bone-health plan while consuming AlgaeCal 2
    Intervention: Dietary Supplement: AlgaeCal-2
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
354
March 2010
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01114685
AlgaeCal 1 & 2
Yes
Gilbert R. Kaats, PhD, Integrative Health Technologies, Inc.
Integrative Health Technologies, Inc.
AlgaeCal Inc.
Principal Investigator: Gilbert R Kaats, PhD Integrative Health Technologies
Principal Investigator: Harry G Preuss, MD Georgetown University
Integrative Health Technologies, Inc.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP