OsteoporosisNCT04550078
The Postprandial Calcium Absorption of a Milk Derived Calcium Permeate - RENEW Acute Study
A study testing Calcium Carbonate and Calcium Permeate in people with Osteoporosis, run by Inge Tetens at 1 site in Denmark.
Trial summary
This is a randomized controlled cross-over meal study with the overall aim to investigate the postprandial calcium absorption from calcium permeate compared with calcium carbonate. The hypothesis is that the bioavailability of calcium permeate is equal to or higher than calcium carbonate. 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
- What is being tested?
- Calcium Carbonate and Calcium Permeate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Jul 2020to 6 Nov 2020
- 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
- Subject is >50 years and <65 years of age by the time of inclusion.
- Subject has been menopausal for 2-5 years.
- Subject willing and able to meet at University Hospital, Køge for three whole days in one month.
- Subject is non-smoking or able not to smoke during clinic visits.
- Subject with no history of osteoporotic fractures.
- Subject is willing and able to provide written informed consent prior to participation.
Who cannot join
- Subject taking supplements or medicine that affects calcium and bone metabolism e.g. diuretics or hormone replacement therapy.
- Subject with vitamin D insufficiency defined as ≤50nmol/l.
- Subject with an osteoporosis diagnosis.
- Presence of renal, gastrointestinal, hepatic or endocrinological diseases.
- Subject with any serious illness e.g. cancer.
- Subject with lactose intolerance.
Show all 10Show fewer
- Subject with celiac disease.
- Known or suspected abuse of alcohol or recreational drugs.
- Known or suspected hypersensitivity to trial products or related products.
- Subject where it is not possible to obtain sufficient data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Postprandial Calcium Absorption of a Milk Derived Calcium Permeate - A Randomized Controlled Cross-over Meal Study
This is a randomized controlled cross-over meal study with the overall aim to investigate the postprandial calcium absorption from calcium permeate compared with calcium carbonate. The hypothesis is that the bioavailability of calcium permeate is equal to or higher than calcium carbonate. This will be investigated in a cross-over design with 10 postmenopausal women age 50-65 as subjects.
- Conditions
- Osteoporosis
- Being tested
- Calcium Carbonate, Calcium Permeate, Placebo
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium CarbonateDietary supplement
Subjects receive a single-dose of 800 mg calcium as calcium carbonate provided in 6 capsules with a standardized breakfast served in the morning.
Calcium PermeateDietary supplement
Also called Capolac
Subjects receive a single-dose of 800 mg milk calcium as calcium permeate provided in 6 capsules with a standardized breakfast served in the morning.
PlaceboDietary supplement
Subjects receive a single-dose of 0 mg calcium as placebo with maltodextrin provided in 6 capsules with a standardized breakfast served in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Calcium Carbonate | Active comparator | 800 mg calcium as calcium carbonate in capsules consumed orally once with a standardized meal. Receives: Dietary Supplement: Calcium Carbonate |
| Calcium-enriched permeate | Experimental | 800 mg calcium as calcium permeate in capsules consumed orally once with a standardized meal. Receives: Dietary Supplement: Calcium Permeate |
| Maltodextrin | Placebo comparator | 0 mg calcium as placebo capsules with maltodextrin consumed orally once with a standardized meal. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Ionized calcium concentration
Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample will be collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).
Measured: 3 months
Secondary outcomes (7)
Serum calcium concentration
Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample is collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).
Measured: 3 months
Serum phosphate concentration
Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample is collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).
Measured: 3 months
Serum magnesium concentration
Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample is collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).
Measured: 3 months
Serum PTH concentration
Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample is collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).
Measured: 3 months
Urinary calcium concentration
Subjects are instructed in 24 hour urine collection for each visit. On visit days two spot-urine samples will be sent for analysis. Samples will be collected at baseline and 360 minutes after ingestion of study products (calcium carbonate, calcium permeate and placebo)
Measured: 3 months
Urine phosphate concentration
Subjects are instructed in 24 hour urine collection for each visit. On visit days two spot-urine samples will be sent for analysis. Samples will be collected at baseline and 360 minutes after ingestion of study products (calcium carbonate, calcium permeate and placebo)
Measured: 3 months
Urine magnesium concentration
Subjects are instructed in 24 hour urine collection for each visit. On visit days two spot-urine samples will be sent for analysis. Samples will be collected at baseline and 360 minutes after ingestion of study products (calcium carbonate, calcium permeate and placebo)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start22 Jul 2020
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inge Tetens
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital, Arla Foods, University of Aarhus, Innovation Fund Denmark
- Responsible party
- Sponsor-investigator, Inge Tetens, University of Copenhagen
- Investigators
- Inge Tetens, Professor, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550078
- Sponsor's protocol ID
- M235
- Status last verified
- Nov 2020
- First submitted
- 10 Aug 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Postprandial Calcium Absorption of a Milk Derived Calcium Permeate - A Randomized Controlled Cross-over Meal Study
- ClinicalTrials.gov ID
- NCT04550078
- Acronym / sponsor ID
- M235
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Inge TetensUniversity, hospital or other
- Collaborators
- Zealand University Hospital, Arla Foods, University of Aarhus, Innovation Fund Denmark
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 16 Sep 2020 (actual)
- 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.
This is a randomized controlled cross-over meal study with the overall aim to investigate the postprandial calcium absorption from calcium permeate compared with calcium carbonate. The hypothesis is that the bioavailability of calcium permeate is equal to or higher than calcium carbonate. This will be investigated in a cross-over design with 10 postmenopausal women age 50-65 as subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcium Carbonate | Active comparator | Dietary Supplement: Calcium Carbonate800 mg calcium as calcium carbonate in capsules consumed orally once with a standardized meal. |
| Calcium-enriched permeate | Experimental | Dietary Supplement: Calcium Permeate800 mg calcium as calcium permeate in capsules consumed orally once with a standardized meal. |
| Maltodextrin | Placebo comparator | Dietary Supplement: Placebo0 mg calcium as placebo capsules with maltodextrin consumed orally once with a standardized meal. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is >50 years and <65 years of age by the time of inclusion.
- Subject has been menopausal for 2-5 years.
- Subject willing and able to meet at University Hospital, Køge for three whole days in one month.
- Subject is non-smoking or able not to smoke during clinic visits.
- Subject with no history of osteoporotic fractures.
Key exclusion criteria (10 listed)
- Subject taking supplements or medicine that affects calcium and bone metabolism e.g. diuretics or hormone replacement therapy.
- Subject with vitamin D insufficiency defined as ≤50nmol/l.
- Subject with an osteoporosis diagnosis.
- Presence of renal, gastrointestinal, hepatic or endocrinological diseases.
- Subject with any serious illness e.g. cancer.
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 CarbonateSubjects receive a single-dose of 800 mg calcium as calcium carbonate provided in 6 capsules with a standardized breakfast served in the morning. | Dietary supplement | Calcium Carbonate |
| Calcium PermeateAlso: CapolacSubjects receive a single-dose of 800 mg milk calcium as calcium permeate provided in 6 capsules with a standardized breakfast served in the morning. | Dietary supplement | Calcium-enriched permeate |
| PlaceboSubjects receive a single-dose of 0 mg calcium as placebo with maltodextrin provided in 6 capsules with a standardized breakfast served in the morning. | Dietary supplement | Maltodextrin |
Primary outcome
Serum Ionized calcium concentration
Time frame: 3 months
Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample will be collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).
7 secondary outcomes
Serum calcium concentration
Time frame: 3 months
Serum phosphate concentration
Time frame: 3 months
Serum magnesium concentration
Time frame: 3 months
Serum PTH concentration
Time frame: 3 months
Urinary calcium concentration
Time frame: 3 months
Urine phosphate concentration
Time frame: 3 months
Urine magnesium concentration
Time frame: 3 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 17 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Inge Tetens, Professor principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Carbonate and Calcium Permeate in people with Osteoporosis, run by Inge Tetens at 1 site in Denmark.
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 6 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 17 Nov 2020. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Serum Ionized calcium concentration (time frame: 3 months). 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 17 Nov 2020.