Bone HealthPhase 3CalkidsNCT01058109
Study of the Effect of a Calcium-rich Diet on Bone Health in Girls
A Phase 3 study testing calcium-rich diet and Calcium rich diet in people with Bone Health, run by Creighton University at 1 site in United States.
Trial summary
The aim of this experimental study was to test the effect of increasing dietary calcium intake to 1500 mg/day on increases in bone quality in adolescent females. The hypothesis to be tested is: adolescent females who consume a high calcium diet will have a greater increase in bone quality, as measured by densitometry… Read more about this study
- Who is it for?
- Ages 9 to 9 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Health
- What is being tested?
- calcium-rich diet and Calcium rich diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1997to Dec 2008
- Phase
- Phase 3
- 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 9 to 9 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Inclusion criteria were being female and nine years of age with usual dietary calcium intake 1100 mg/day or less.
Who cannot join
- Exclusion criteria included history of any of the following: lactose intolerance, milk allergy, corticosteroid or anticonvulsant therapy, familial hypercholesterolemia, mental or physical handicaps, cancer, rheumatoid arthritis, asthma, or any significant health problem reported by the parents. We also excluded any child who had a body mass index (BMI)85th percentile for age and gender and children who practiced or played any organized sport (including gymnastics or dance) more than three times per week.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Calcium Foods on Bone Quality in Pubertal Females
The aim of this experimental study was to test the effect of increasing dietary calcium intake to 1500 mg/day on increases in bone quality in adolescent females. The hypothesis to be tested is: adolescent females who consume a high calcium diet will have a greater increase in bone quality, as measured by densitometry and ultrasound, than adolescent females who consume their usual dietary calcium intake.
- Conditions
- Bone Health
- Being tested
- calcium-rich diet, Calcium rich diet
- Keywords
- bone health, bone density, bone mass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium-rich dietOther
dietary calcium intake of 1500 mg/d
Calcium rich dietOther
dietary intake of 1500 mg/d from food
| Study group | Role | What they receive |
|---|---|---|
| calcium group | Experimental | dietary calcium intake of 1500 mg/d Receives: Other: calcium-rich diet |
| calcium-rich diet (1500 mg/d) | Experimental | calcium intake from food Receives: Other: Calcium rich diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The specific aim of this project was to test the effect of increasing dietary calcium intake to 1500 mg/day on increases in bone quality in pubertal females beginning at age nine.
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startSep 1997
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone HealthStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Lappe, Creighton University
- Investigators
- Joan M Lappe, PhD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058109
- Sponsor's protocol ID
- 97-11179
- Acronym
- Calkids
- Status last verified
- Mar 2016
- First submitted
- 27 Jan 2010
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calcium Foods on Bone Quality in Pubertal Females
- ClinicalTrials.gov ID
- NCT01058109
- Acronym / sponsor ID
- Calkids / 97-11179
- Conditions
- Bone Health
- Keywords
- bone health, bone density, bone mass
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Sep 1997
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Jan 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.
The aim of this experimental study was to test the effect of increasing dietary calcium intake to 1500 mg/day on increases in bone quality in adolescent females. The hypothesis to be tested is: adolescent females who consume a high calcium diet will have a greater increase in bone quality, as measured by densitometry and ultrasound, than adolescent females who consume their usual dietary calcium intake.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcium group | Experimental | Other: calcium-rich dietdietary calcium intake of 1500 mg/d |
| calcium-rich diet (1500 mg/d) | Experimental | Other: Calcium rich dietcalcium intake from food |
Who may qualify
- Ages
- 9 to 9 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Inclusion criteria were being female and nine years of age with usual dietary calcium intake 1100 mg/day or less.
Key exclusion criteria (1 listed)
- Exclusion criteria included history of any of the following: lactose intolerance, milk allergy, corticosteroid or anticonvulsant therapy, familial hypercholesterolemia, mental or physical handicaps, cancer, rheumatoid arthritis, asthma, or any significant health problem reported by the parents. We also excluded any child who had a body mass index (BMI)85th percentile for age and gender and children who practiced or played any organized sport (including gymnastics or dance) more than three times per week.
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 |
|---|---|---|
| calcium-rich dietdietary calcium intake of 1500 mg/d | Other | calcium group |
| Calcium rich dietdietary intake of 1500 mg/d from food | Other | calcium-rich diet (1500 mg/d) |
Primary outcome
The specific aim of this project was to test the effect of increasing dietary calcium intake to 1500 mg/day on increases in bone quality in pubertal females beginning at age nine.
Time frame: 9 years
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 28 Mar 2016.
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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.
Joan M Lappe, PhD principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing calcium-rich diet and Calcium rich diet in people with Bone Health, run by Creighton University 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 1 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 28 Mar 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The specific aim of this project was to test the effect of increasing dietary calcium intake to 1500 mg/day on increases in bone quality in pubertal females beginning at age nine. (time frame: 9 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2016.