OsteoporosisFL-83NCT01394484
Dairy Foods Compared to Dietary Supplements and Bone Health
A study testing Intervention I and Intervention II in people with Osteoporosis and Bone Loss, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial summary
Does the consumption of dairy foods reduce the rate of bone loss in older women more than calcium and vitamin D supplements. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Bone Loss, Osteopenia
- What is being tested?
- Intervention I and Intervention II
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Feb 2013
- 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 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum 24 months since last menses
- No hormone therapy in the past 12 months
- Weight stable for the past 3 months
- Bone density T score -1.7 to 0.0
- No more than two dairy servings per day
- No history of inflammatory disorders
Show all 10Show fewer
- No history of non-traumatic bone fracture
- No supplement use or willing to discontinue
- No lactose intolerance
- Willing to consume milk and yogurt
Who cannot join
- Less than 24 months since last menses
- Use of hormone therapy in past yr
- > 5 pound weight change in past 3 months
- Osteoporosis
- Regular >2 servings/d of dairy
- Auto-immune/inflammatory disorders
Show all 10Show fewer
- History of non-traumatic bone fracture
- Unwilling to discontinue supplements
- Lactose intolerance
- Unwilling to eat yogurt or drink milk
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Human Nutrition Research Center
Davis, California, 95616
About this study
Official title: Milk and Yogurt vs. Calcium and Vitamin D Supplements for Bone Health of Women
Does the consumption of dairy foods reduce the rate of bone loss in older women more than calcium and vitamin D supplements.
Read the detailed description
Research indicates that bone health is dependent on multiple nutrients, not just calcium and vitamin D, leading to the conclusion that calcium from sources that include other bone enhancing nutrients may be more effective in maintaining bone integrity than calcium and vitamin D supplements. Several studies have examined the effects of calcium intake from dairy foods on different indicators of bone health. Reducing the rate of bone loss in postmenopausal women can reduce the risk of osteoporosis related fractures. Therefore we propose to study the effectiveness of 4 servings of milk and yogurt per day for 42 days compared to calcium and vitamin D supplements for 42 days to reduce calcium loss from the skeleton in post menopausal women. Postmenopausal women, approximately 50-65 years of age, will be studied. Each volunteer will receive both interventions in a cross-over design, in random order, separated by a 42 day washout period.
- Conditions
- Osteoporosis, Bone Loss, Osteopenia
- Being tested
- Intervention I, Intervention II
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention IOther
Four servings of dairy foods (milk and yogurt) per day for 42 days.
Intervention IIDietary supplement
1200 mg of supplemental calcium and 400 IU of vitamin D3 for 42 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Four servings of dairy foods per day for 42 days, followed by washout for 42 days, followed by dietary supplements for 42 days Receives: Other: Intervention I; Dietary Supplement: Intervention II |
| Arm 2 | Experimental | Dietary Supplements for 42 days, followed by washout for 42 days, followed by 4 servings of dairy foods for 42 days. Receives: Other: Intervention I; Dietary Supplement: Intervention II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of 41Ca/40Ca excreted in urine
Subjects will be asked to collect 24 hour urine samples to establish each individual's kinetic profile of Ca excretion and to measure the effectiveness of the interventions.
Measured: Days 0, 90, 120, 150, 180, 187, 194, 201, 208, 215, 222, 229, 236, 243, 250, 257, 264,271, 278, 285, 292, 299, and 306 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startDec 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- Dairy Management Inc.
- Responsible party
- Sponsor
- Investigators
- Marta Van Loan, PhD, Principal investigator, WHNRC, ARS, University of California DavisMarjorie Garrod, Ph.D., Study director, USDA, ARS, WHNRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394484
- Sponsor's protocol ID
- WHNRC 201018566-1
- Acronym
- FL-83
- Status last verified
- Feb 2013
- First submitted
- 12 Jul 2011
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milk and Yogurt vs. Calcium and Vitamin D Supplements for Bone Health of Women
- ClinicalTrials.gov ID
- NCT01394484
- Acronym / sponsor ID
- FL-83 / WHNRC 201018566-1
- Conditions
- Osteoporosis, Bone Loss, Osteopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- Dairy Management Inc.
- Study start
- Dec 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 14 Jul 2011 (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.
Does the consumption of dairy foods reduce the rate of bone loss in older women more than calcium and vitamin D supplements.
Detailed description
Research indicates that bone health is dependent on multiple nutrients, not just calcium and vitamin D, leading to the conclusion that calcium from sources that include other bone enhancing nutrients may be more effective in maintaining bone integrity than calcium and vitamin D supplements. Several studies have examined the effects of calcium intake from dairy foods on different indicators of bone health. Reducing the rate of bone loss in postmenopausal women can reduce the risk of osteoporosis related fractures. Therefore we propose to study the effectiveness of 4 servings of milk and yogurt per day for 42 days compared to calcium and vitamin D supplements for 42 days to reduce calcium loss from the skeleton in post menopausal women. Postmenopausal women, approximately 50-65 years of age, will be studied. Each volunteer will receive both interventions in a cross-over design, in random order, separated by a 42 day washout period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Intervention I, Dietary Supplement: Intervention IIFour servings of dairy foods per day for 42 days, followed by washout for 42 days, followed by dietary supplements for 42 days |
| Arm 2 | Experimental | Other: Intervention I, Dietary Supplement: Intervention IIDietary Supplements for 42 days, followed by washout for 42 days, followed by 4 servings of dairy foods for 42 days. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Minimum 24 months since last menses
- No hormone therapy in the past 12 months
- Weight stable for the past 3 months
- Bone density T score -1.7 to 0.0
- No more than two dairy servings per day
Key exclusion criteria (10 listed)
- Less than 24 months since last menses
- Use of hormone therapy in past yr
- > 5 pound weight change in past 3 months
- Osteoporosis
- Regular >2 servings/d of dairy
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 |
|---|---|---|
| Intervention IFour servings of dairy foods (milk and yogurt) per day for 42 days. | Other | Arm 1, Arm 2 |
| Intervention II1200 mg of supplemental calcium and 400 IU of vitamin D3 for 42 days | Dietary supplement | Arm 1, Arm 2 |
Primary outcome
Ratio of 41Ca/40Ca excreted in urine
Time frame: Days 0, 90, 120, 150, 180, 187, 194, 201, 208, 215, 222, 229, 236, 243, 250, 257, 264,271, 278, 285, 292, 299, and 306 of the study
Subjects will be asked to collect 24 hour urine samples to establish each individual's kinetic profile of Ca excretion and to measure the effectiveness of the interventions.
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 26 Feb 2013.
- USDA Western Human Nutrition Research CenterLink provided by the sponsor.
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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.
Marta Van Loan, PhD principal investigator
WHNRC, ARS, University of California Davis
Marjorie Garrod, Ph.D. study director
USDA, ARS, WHNRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention I and Intervention II in people with Osteoporosis and Bone Loss, run by USDA, Western Human Nutrition Research Center 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 10 inclusion and 10 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 26 Feb 2013. 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?
Ratio of 41Ca/40Ca excreted in urine (time frame: Days 0, 90, 120, 150, 180, 187, 194, 201, 208, 215, 222, 229, 236, 243, 250, 257, 264,271, 278, 285, 292, 299, and 306 of the study). 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 26 Feb 2013.