OsteopeniaNCT01114685
A Comparison of Changes in Bone Density With the Same Bone-health Plan, But With Different Bone-health Supplements
A study testing AlgaeCal-1 and AlgaeCal-2 in people with Osteopenia, run by Integrative Health Technologies, Inc. at 1 site in United States.
Trial summary
A comparison of changes in bone density following the same bone-health plan, but with a different bone-health supplement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteopenia
- What is being tested?
- AlgaeCal-1 and AlgaeCal-2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects were required to contact the physicians to ensure they had no medical issues that would preclude their participation.
Who cannot join
- Younger the 18 years of age, and
- Recommendations not to participate from their physicians.
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Health Technologies
San Antonio, Texas, 78209
About this study
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
A comparison of changes in bone density following the same bone-health plan, but with a different bone-health supplement.
Read the 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:
- 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.
- Conditions
- Osteopenia
- Being tested
- AlgaeCal-1, AlgaeCal-2
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlgaeCal-1Dietary supplement
Daily consumption of 7 capsules containing bone health ingredients
AlgaeCal-2Dietary supplement
Taking 7 capsules a day for six months
| Study group | Role | What they receive |
|---|---|---|
| Effects of taking AlgaeCal-1 | Active comparator | Following a bone health plan with Algae-cal-1 supplement Receives: Dietary Supplement: AlgaeCal-1 |
| Effects of taking AlgaeCal-2 | Active comparator | Following a bone-health plan while consuming AlgaeCal 2 Receives: Dietary Supplement: AlgaeCal-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 6 months
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
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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startJun 2006
- Primary completionJul 2008
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrative Health Technologies, Inc.
- Sponsor type
- Research network
- Collaborators
- AlgaeCal Inc.
- Investigators
- Gilbert R Kaats, PhD, Principal investigator, Integrative Health TechnologiesHarry G Preuss, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114685
- Sponsor's protocol ID
- AlgaeCal 1 & 2
- Status last verified
- Apr 2010
- First submitted
- 19 Apr 2010
- Last updated
- 3 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21492428
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01114685
- Acronym / sponsor ID
- AlgaeCal 1 & 2
- Conditions
- Osteopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Integrative Health Technologies, Inc.Research network
- Collaborators
- AlgaeCal Inc.
- Study start
- Jun 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 3 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A comparison of changes in bone density following the same bone-health plan, but with a different bone-health supplement.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effects of taking AlgaeCal-1 | Active comparator | Dietary Supplement: AlgaeCal-1Following a bone health plan with Algae-cal-1 supplement |
| Effects of taking AlgaeCal-2 | Active comparator | Dietary Supplement: AlgaeCal-2Following a bone-health plan while consuming AlgaeCal 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All subjects were required to contact the physicians to ensure they had no medical issues that would preclude their participation.
Key exclusion criteria (2 listed)
- Younger the 18 years of age, and
- Recommendations not to participate from their physicians.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlgaeCal-1Daily consumption of 7 capsules containing bone health ingredients | Dietary supplement | Effects of taking AlgaeCal-1 |
| AlgaeCal-2Taking 7 capsules a day for six months | Dietary supplement | Effects of taking AlgaeCal-2 |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2010.
- Derived from this study: PubMed 21492428Michalek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilbert R Kaats, PhD principal investigator
Integrative Health Technologies
Harry G Preuss, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AlgaeCal-1 and AlgaeCal-2 in people with Osteopenia, run by Integrative Health Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Bone Mineral Density (BMD) (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01114685, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2010.