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Completed

NCT Number: NCT01114685

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

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

Completed

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Key information

Conditions

Osteopenia Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Health Technologies

San Antonio, Texas, 78209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AlgaeCal-1

Dietary Supplement

Daily consumption of 7 capsules containing bone health ingredients

AlgaeCal-2

Dietary Supplement

Taking 7 capsules a day for six months

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Integrative Health Technologies, Inc.

Network

Collaborators

  • AlgaeCal Inc.

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2010
First posted
May 3, 2010
Registry last updated
May 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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