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

Osteopenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114685
• Other study ID #: AlgaeCal 1 & 2
• Status: Completed
• Phase: N/A
• First received: April 19, 2010
• Last updated: April 30, 2010
• Start date: June 2006
• Est. completion date: March 2010

Study information

• Verified date: April 2010
• Source: Integrative Health Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: March 2010
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteopenia

Intervention

Dietary Supplement:
• AlgaeCal-1
Daily consumption of 7 capsules containing bone health ingredients
• AlgaeCal-2
Taking 7 capsules a day for six months

Locations

Country	Name	City	State
United States	Integrative Health Technologies	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Health Technologies, Inc.	AlgaeCal Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	A comparison of changes from baseline in 43-blood chemistry panel and a self-reported quality of life inventory in both study groups	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.	six months	Yes