Calcium DeficiencyPhase 1OsteoproNCT01639222

Human Pharmacology Trial of Calcium-vitamin D3 Tablet in Healthy Participants

A Phase 1 study testing Calcium 500 mg and Vitamin D3 800 IU and Low calcium meals in people with Calcium Deficiency and Vitamin D Deficiency, run by Takeda at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to demonstrate that the intestinal absorption of calcium from a newly developed calcium carbonate-vitamin D3 chewable tablet formulation increases the amount of calcium excreted in urine and decreases parathyroid hormone (PTH) in serum as compared to baseline. Read more about this study

Who is it for?: Ages 45 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Calcium Deficiency, Vitamin D Deficiency
What is being tested?: Calcium 500 mg and Vitamin D3 800 IU and Low calcium meals
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteGermany
Study dates: Jul 2012to Aug 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Is a healthy postmenopausal woman (last menses at least 2 years before signing informed consent and follicle stimulating hormone (FSH) confirming postmenopausal status) or a healthy male aged between 45 to 70 years inclusively
Was informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which she/he might be exposed, and had given written consent to participation in the trial prior to any trial-related procedure
Is Caucasian
Is assessed as healthy based on physical examination, medical history, clinical laboratory, electrocardiogram (ECG), vital signs
Is a non-smoker (having abstained from smoking for at least 6 months)
Has a body mass index of 19 to 29.4 kg/m^2 (inclusively)

Who cannot join

Has a history of clinically significant allergies or idiosyncrasies to calcium or vitamin D3, or any inactive ingredient(s) of these products
Is a lactating or pregnant female participant
Female participants: Has a positive pregnancy test in serum at screening and in urine on Day -1 Period 1
Participant was previously enrolled into the current clinical trial
Has participated in the active treatment phase of another clinical trial where a persisting pharmacodynamic (PD) effect of the IMP of that clinical trial cannot be excluded (e.g. patient is well into a treatment free safety follow-up phase); or 10 times the pharmacokinetic (PK) half-life, whatever is longer but 30 days as minimum prior to the start of the clinical trial
Has been considered unable or unwilling to co-operate adequately, i.e. to follow clinical trial procedures and Investigator instructions adequately (e.g. language difficulties, etc.) or participant is anticipated not to be available for scheduled clinical trial visits/procedures

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Has a dependency situation (e.g. person is kept in detention, Investigator in the current clinical trial, or a first-degree relative of a clinical trial Investigator, or is employee at the clinical trial site)
Has a hypersensitivity to soya or peanut
Abuse of alcohol or drugs
Has consumed ethanol within 48 hours prior to hospitalization verified by alcohol breath test (Alcotest®)
Has a history or current disease which might influence the trial objectives (e.g., urinary tract infection, urination problems [e.g., prostate hyperplasia] or urinary incontinence, renal insufficiency, nephrolithiasis, sarcoidosis, osteoporosis, calcium deficiency, hyper- or hypoparathyroidism, hypercalciuria, hypercalcaemia, calcium lithiasis, hyperphosphataemia, hypervitaminosis D, phenylketonuria, diabetes mellitus
Has creatinine clearance according to Modification of Diet in Renal Disease (MDRD) equation of < 60 mL/min
Has regular use of any medication. Treatment with biphosphonates in the past 5 years, amidorone in the past 6 months, calcium or fluoride supplements, diuretics, vitamin D preparations, estrogens or estrogen receptor modulators, enzyme inducing agents, teriparatide or parathyroid hormone (PTH(1-84)), bile sequestrants within 3 months before screening, and for all other drugs within 2 weeks before screening (or 6 times the half-life of the respective drug) whatever is longer
Has use of ultraviolet radiation cabins or sunbath longer than 1 h from 1 week before Day 1 of Period 1 until the End of Trial examination
Has an intake of milk and milk products, broccoli, dark-green vegetables, vegetables from the mustard green family, fatty fish, eggs, liver, and added salt within 7 days prior to hospitalisation
Has unusual diet habits and practicing vegetarians
Has beverages and food containing poppy seed (i.e. poppy seed rolls, poppy seed cake, milk shakes containing poppy seed) from 72 hours before drug screen to avoid interference
Has chinine, grapefruit- and star fruit-containing beverages and food, St. John's wort (known Cytochrome P450 (CYP450) inhibitors and inducers) within 7 days prior to hospitalization
Has excessive consumption of caffeinated beverages (more than five cups of coffee or equivalent per day)
Has consumption of xanthine-containing beverages and food (e.g. coffee, black and green tea, cola, chocolate) 48 hours prior to hospitalization
Has evidence of acute or chronic hepatitis B or C. Positive test for hepatitis B surface antigen (HBsAg), antibody to the hepatitis B core antigen (anti-HBc) or antibody to the hepatitis C virus (anti-HCV antibody), or human immunodeficiency virus (HIV) infection at screening
Has history of gastrointestinal surgery (except appendectomy) or any other gastrointestinal condition or disease that might influence (calcium) absorption
Has any condition, including laboratory findings or findings in the medical history or screening assessments that, in the opinion of the Investigator, constitutes a specific risk or a contraindication for the participant's participation in the trial or that could interfere with the trial objectives, conduct or evaluation
Has any comedication required during the trial.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Mannheim, Baden-Wurttemberg

Other trials in Germany

About this study

Official title: A Two Period, One-sequence Open-label Study of a Newly Developed Calcium Carbonate-vitamin D3 Chewable Tablet Formulation (Calcium 500 mg and Vitamin D3 800) Dosed for Three Days to Investigate the Effect on Urine Calcium and Serum Parathyroid Hormone (PTH) as Measurements of Intestinal Calcium Absorption in Healthy Postmenopausal Women and Healthy Men Compared to Baseline.

Read the detailed description

The drug being tested in this study is called Calcichew. This study will look at calcium absorption in healthy postmenopausal women and healthy men.

The study will enroll approximately 55 healthy adults. All participants will receive Calcichew.

All participants will be asked to take one chewable tablet at the same time each day for three days in period 2 of the trial.

This trial will be conducted at one clinical site in Germany. The overall time to participate in this study is 4 weeks. Participants will make 9 visits to the clinic, and will be contacted by telephone 7days after last dose of study drug for a follow-up assessment.

Conditions: Calcium Deficiency, Vitamin D Deficiency
Being tested: Calcium 500 mg and Vitamin D3 800 IU, Low calcium meals
Keywords: Drug therapy, Increase in calcium urinary excretion and PTH decrease in serum
Medical subject headings: Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Calcium 500 mg and Vitamin D3 800 IUDrug
Also called Calcichew-D3 forte 500 mg/800 IU
Calcium 500 mg and Vitamin D3 800 IU chewable tablets
Low calcium mealsOther
A normal Western European diet with reduced calcium content (400 mg per day).

Study groups in NCT01639222
Study group	Role	What they receive
Calcium 500 mg and Vitamin D3 800 IU	Experimental	Period 1: Low calcium meals for up to 3 days. Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals. Receives: Drug: Calcium 500 mg and Vitamin D3 800 IU; Other: Low calcium meals

What is being measured

The primary outcome is the main question the study is designed to answer.

Amount of Calcium Excreted in Urine From 0 Hours up to 6 Hours Post Dose (Ca2+ Ae0-6h)
Ca2+ Ae0-6h was calculated as the urine volume of the urine collected from 0 to 6 hours multiplied by the calcium concentration measured in urine.
Measured: Day 3 of Period 1 (Reference) and Day 3 in Period 2. Samples were taken 0-6 Hours post dose
Area Under the Curve From 0 to 6 Hours Post Dose of Parathyroid Hormone (PTH AUC0-6h) in Serum
The area under the curve from 0 to 6 hours post dose of parathyroid hormone (PTH AUC0-6h) in serum, calculated using the linear trapezoidal formula.
Measured: Day 3 in Period 1 (Reference) and Day 3 in Period 2. Samples were taken at predose, 0.5, 1, 2, 3, 4, and 6 hour post dose.

Secondary outcomes (1)

Amount of Calcium Excreted in Urine From 0 to 6 Hours Post Dose Corected for Creatinine (Ae0-6h/Creatinine)
To account for potential inaccuracies in urine collection, creatinine correction of calcium excretion was also assessed. Ca2+ Ae0-6h/Creatinine was obtained by dividing the urinary concentration of calcium by the urinary creatinine concentration.
Measured: Day 3 of Period 1 (Baseline) and Day 3 in Period 2. Samples will be taken 0-6 Hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Aug 2012

First posted12 Jul 2012 (estimated)
Study startJul 2012
Primary completionAug 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Calcium DeficiencyStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01639222
Sponsor's protocol ID: CW-2200-401-RD
Other IDs: 2011-005786-21, U1111-1124-2328
Acronym: Osteopro
Status last verified: Aug 2013
First submitted: 9 Jul 2012
Last updated: 18 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Calcium Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two Period, One-sequence Open-label Study of a Newly Developed Calcium Carbonate-vitamin D3 Chewable Tablet Formulation (Calcium 500 mg and Vitamin D3 800) Dosed for Three Days to Investigate the Effect on Urine Calcium and Serum Parathyroid Hormone (PTH) as Measurements of Intestinal Calcium Absorption in Healthy Postmenopausal Women and Healthy Men Compared to Baseline.
ClinicalTrials.gov ID: NCT01639222
Acronym / sponsor ID: Osteopro / CW-2200-401-RD
Conditions: Calcium Deficiency, Vitamin D Deficiency
Keywords: Drug therapy, Increase in calcium urinary excretion and PTH decrease in serum
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 12 Jul 2012 (estimated)
Results: Posted 18 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The drug being tested in this study is called Calcichew. This study will look at calcium absorption in healthy postmenopausal women and healthy men.

The study will enroll approximately 55 healthy adults. All participants will receive Calcichew.

All participants will be asked to take one chewable tablet at the same time each day for three days in period 2 of the trial.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Calcium 500 mg and Vitamin D3 800 IU	Experimental	Drug: Calcium 500 mg and Vitamin D3 800 IU, Other: Low calcium mealsPeriod 1: Low calcium meals for up to 3 days. Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals.

Who may qualify

Ages: 45 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Is a healthy postmenopausal woman (last menses at least 2 years before signing informed consent and follicle stimulating hormone (FSH) confirming postmenopausal status) or a healthy male aged between 45 to 70 years inclusively
Was informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which she/he might be exposed, and had given written consent to participation in the trial prior to any trial-related procedure
Is Caucasian
Is assessed as healthy based on physical examination, medical history, clinical laboratory, electrocardiogram (ECG), vital signs
Is a non-smoker (having abstained from smoking for at least 6 months)

Key exclusion criteria (24 listed)

Has a history of clinically significant allergies or idiosyncrasies to calcium or vitamin D3, or any inactive ingredient(s) of these products
Is a lactating or pregnant female participant
Female participants: Has a positive pregnancy test in serum at screening and in urine on Day -1 Period 1
Participant was previously enrolled into the current clinical trial
Has participated in the active treatment phase of another clinical trial where a persisting pharmacodynamic (PD) effect of the IMP of that clinical trial cannot be excluded (e.g. patient is well into a treatment free safety follow-up phase); or 10 times the pharmacokinetic (PK) half-life, whatever is longer but 30 days as minimum prior to the start of the clinical trial

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 500 mg and Vitamin D3 800 IUAlso: Calcichew-D3 forte 500 mg/800 IUCalcium 500 mg and Vitamin D3 800 IU chewable tablets	Drug	Calcium 500 mg and Vitamin D3 800 IU
Low calcium mealsA normal Western European diet with reduced calcium content (400 mg per day).	Other	Calcium 500 mg and Vitamin D3 800 IU

Primary outcome

Amount of Calcium Excreted in Urine From 0 Hours up to 6 Hours Post Dose (Ca2+ Ae0-6h)
Time frame: Day 3 of Period 1 (Reference) and Day 3 in Period 2. Samples were taken 0-6 Hours post dose
Ca2+ Ae0-6h was calculated as the urine volume of the urine collected from 0 to 6 hours multiplied by the calcium concentration measured in urine.
Area Under the Curve From 0 to 6 Hours Post Dose of Parathyroid Hormone (PTH AUC0-6h) in Serum
Time frame: Day 3 in Period 1 (Reference) and Day 3 in Period 2. Samples were taken at predose, 0.5, 1, 2, 3, 4, and 6 hour post dose.
The area under the curve from 0 to 6 hours post dose of parathyroid hormone (PTH AUC0-6h) in serum, calculated using the linear trapezoidal formula.

1 secondary outcome

Amount of Calcium Excreted in Urine From 0 to 6 Hours Post Dose Corected for Creatinine (Ae0-6h/Creatinine)
Time frame: Day 3 of Period 1 (Baseline) and Day 3 in Period 2. Samples will be taken 0-6 Hours postdose

Results and safety

Results posted to the registry on 18 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Calcium 500 mg and Vitamin D3 800 IU	55	55

Primary outcome: Amount of Calcium Excreted in Urine From 0 Hours up to 6 Hours Post Dose (Ca2+ Ae0-6h)

Time frame: Day 3 of Period 1 (Reference) and Day 3 in Period 2. Samples were taken 0-6 Hours post dose. Mean (Standard Deviation). Unit: mmol

Measure	Calcium 500 mg and Vitamin D3 800 IU n = 55	Reference Treatment n = 55
Value	1.07 (0.49)	0.63 (0.43)

Calcium 500 mg and Vitamin D3 800 IU vs Reference Treatment: Calcium-Vitamin D/Reference (%): 179.72 (95% CI 157.16 to 205.52)

Population analysed: The Pharmacokinetic/Pharmacodynamic (PK/PD) Set included all enrolled subjects who received at least one dose of the mock treatment who had reliable values of either the primary PK parameter Ca2+ Ae0-6h in both periods or the primary PD parameter PTH AUC0-6h in both periods.

Primary outcome: Area Under the Curve From 0 to 6 Hours Post Dose of Parathyroid Hormone (PTH AUC0-6h) in Serum

Time frame: Day 3 in Period 1 (Reference) and Day 3 in Period 2. Samples were taken at predose, 0.5, 1, 2, 3, 4, and 6 hour post dose.. Mean (Standard Deviation). Unit: h*pg/mL

Measure	Calcium 500 mg and Vitamin D3 800 IU n = 55	Reference Treatment n = 55
Value	202.02 (63.51)	278.86 (79.71)

Calcium 500 mg and Vitamin D3 800 IU vs Reference Treatment: Calcium-Vitamin D/Reference (%): 71.77 (95% CI 68.83 to 74.84)

Population analysed: PK/PD set

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 13 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Calcium 500 mg and Vitamin D3 800 IU	0 of 55 (0%)	5 of 55 (9.1%)	Not reported
Reference Treatment	0 of 55 (0%)	6 of 55 (10.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Principal, Clinical Pharmacology study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Calcium 500 mg and Vitamin D3 800 IU and Low calcium meals in people with Calcium Deficiency and Vitamin D Deficiency, run by Takeda at 1 site in Germany.

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 24 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 18 Oct 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Amount of Calcium Excreted in Urine From 0 Hours up to 6 Hours Post Dose (Ca2+ Ae0-6h) (time frame: Day 3 of Period 1 (Reference) and Day 3 in Period 2. Samples were taken 0-6 Hours post dose). The study lists 2 primary outcomes in all. 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 NCT01639222.

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 18 Oct 2013.