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

April 30, 2010 updated by: Integrative Health Technologies, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

354

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • Integrative Health Technologies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integrative Health Technologies, Inc.

Collaborators

AlgaeCal Inc.

Investigators

  • Principal Investigator: Gilbert R Kaats, PhD, Integrative Health Technologies
  • Principal Investigator: Harry G Preuss, MD, Georgetown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

April 19, 2010

First Submitted That Met QC Criteria

April 30, 2010

First Posted (Estimate)

May 3, 2010

Study Record Updates

Last Update Posted (Estimate)

May 3, 2010

Last Update Submitted That Met QC Criteria

April 30, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AlgaeCal 1 & 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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