Roux-en-Y Gastric BypassNCT02830789
Investigation of the Optimal Calcium Supplement Following Roux-en-Y Gastric Bypass
A study testing Calcium Carbonate, Calcium Citrate and Roux-en-Y gastric bypass in people with Roux-en-Y Gastric Bypass and Hyperparathyroidism, Secondary, run by University of Aarhus at 1 site in Denmark.
Trial summary
This study investigates whether calcium citrate or calcium carbonate are the optimal supplement to treat secondary hyperparathyroidism following Roux-en-Y gastric bypass operation. Half of the participants will be randomized to receive calcium citrate, while the other half will receive calcium carbonate. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Roux-en-Y Gastric Bypass, Hyperparathyroidism, Secondary
- What is being tested?
- Calcium Carbonate, Calcium Citrate and Roux-en-Y gastric bypass
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2016to May 2017
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Roux-en-Y gastric bypass operation ≥12 months ago
- Parathyroid hormone > 6.9 pmol/l
- Vitamin D > 50 nmol/l
- P-Calcium [1.18-1.32] mmol/l
Who cannot join
- Liver disease
- Renal disease
- Hypercalcemia
- Untreated thyroid disease
- Parathyroid disease except secondary hyperparathyroidism
- Use of diuretics, bisphosphonates, calcitonin, teriparatide, oral corticosteroids, anabolic steroids, calcimimetics, lithium, strontium, denosumab or anticonvulsants within 1 year of inclusion
- abusing alcohol
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Enodocrinology and Internal Medicine, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Investigation of the Optimal Calcium Supplement Following Roux-en-Y Gastric Bypass in Order to Treat Secondary Hyperparathyroidism: A Clinical Randomized Trial
This study investigates whether calcium citrate or calcium carbonate are the optimal supplement to treat secondary hyperparathyroidism following Roux-en-Y gastric bypass operation.
Half of the participants will be randomized to receive calcium citrate, while the other half will receive calcium carbonate. The study will be double blinded.
- Being tested
- Calcium Carbonate, Calcium Citrate, Placebo, Roux-en-Y gastric bypass
- Medical subject headings
- Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium CarbonateDietary supplement
Also called Unikalk Forte
Calcium CitrateDietary supplement
Also called Unikalk Citrat
PlaceboDietary supplement
Tablet manufactured to mimic a calcium carbonate tablet
Roux-en-Y gastric bypassProcedure or surgery
Roux-en-Y gastric bypass surgery at least 12 months before study inclusion
| Study group | Role | What they receive |
|---|---|---|
| Calcium Carbonate | Experimental | 1 tablet Unikalk Forte + 1 placebo tablet by mouth three times daily equal to 1200 mg elementary calcium and 57 µg Vitamin D3 Receives: Dietary Supplement: Calcium Carbonate; Dietary Supplement: Placebo; Procedure: Roux-en-Y gastric bypass |
| Calcium Citrate | Experimental | 2 tablets Unikalk Citrat by mouth three times daily equal to 1200 mg elementary calcium and 60 µg Vitamin D3 Receives: Dietary Supplement: Calcium Citrate; Procedure: Roux-en-Y gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parathyroid Hormone
Measured: Change from baseline at 6 weeks and 12 weeks
Secondary outcomes (12)
Se-ion-calcium
Measured: Change from baseline at 6 weeks and 12 weeks
P-magnesium
Measured: Change from baseline at 6 weeks and 12 weeks
P-phosphate
Measured: Change from baseline at 6 weeks and 12 weeks
P-25-OH-vitamin D
Measured: Change from baseline at 6 weeks and 12 weeks
P-calcitriol
Measured: Change from baseline at 6 weeks and 12 weeks
P-24,25-(OH)2-vitamin D
Measured: Change from baseline at 6 weeks and 12 weeks
Vitamin D binding protein
Measured: Change from baseline at 6 weeks and 12 weeks
Procollagen type 1 N-terminal propeptide (P1NP)
Measured: Change from baseline at 6 weeks and 12 weeks
P-bone specific alkaline phosphatase
Measured: Change from baseline at 6 weeks and 12 weeks
Cross-linked C-telopeptide (CTX)
Measured: Change from baseline at 6 weeks and 12 weeks
24h U-calcium
Measured: Change from baseline at 12 weeks
24h U-phosphate
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startDec 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Roux-en-Y Gastric BypassStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lene Ring Madsen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830789
- Sponsor's protocol ID
- 20160610
- Status last verified
- Jun 2017
- First submitted
- 6 Jul 2016
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Optimal Calcium Supplement Following Roux-en-Y Gastric Bypass in Order to Treat Secondary Hyperparathyroidism: A Clinical Randomized Trial
- ClinicalTrials.gov ID
- NCT02830789
- Acronym / sponsor ID
- 20160610
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 13 Jul 2016 (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.
This study investigates whether calcium citrate or calcium carbonate are the optimal supplement to treat secondary hyperparathyroidism following Roux-en-Y gastric bypass operation.
Half of the participants will be randomized to receive calcium citrate, while the other half will receive calcium carbonate. The study will be double blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium Carbonate | Experimental | Dietary Supplement: Calcium Carbonate, Dietary Supplement: Placebo, Procedure: Roux-en-Y gastric bypass1 tablet Unikalk Forte + 1 placebo tablet by mouth three times daily equal to 1200 mg elementary calcium and 57 µg Vitamin D3 |
| Calcium Citrate | Experimental | Dietary Supplement: Calcium Citrate, Procedure: Roux-en-Y gastric bypass2 tablets Unikalk Citrat by mouth three times daily equal to 1200 mg elementary calcium and 60 µg Vitamin D3 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Roux-en-Y gastric bypass operation ≥12 months ago
- Parathyroid hormone > 6.9 pmol/l
- Vitamin D > 50 nmol/l
- P-Calcium [1.18-1.32] mmol/l
Key exclusion criteria (7 listed)
- Liver disease
- Renal disease
- Hypercalcemia
- Untreated thyroid disease
- Parathyroid disease except secondary hyperparathyroidism
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 CarbonateAlso: Unikalk Forte | Dietary supplement | Calcium Carbonate |
| Calcium CitrateAlso: Unikalk Citrat | Dietary supplement | Calcium Citrate |
| PlaceboTablet manufactured to mimic a calcium carbonate tablet | Dietary supplement | Calcium Carbonate |
| Roux-en-Y gastric bypassRoux-en-Y gastric bypass surgery at least 12 months before study inclusion | Procedure or surgery | Calcium Carbonate, Calcium Citrate |
Primary outcome
Parathyroid Hormone
Time frame: Change from baseline at 6 weeks and 12 weeks
12 secondary outcomes
Se-ion-calcium
Time frame: Change from baseline at 6 weeks and 12 weeks
P-magnesium
Time frame: Change from baseline at 6 weeks and 12 weeks
P-phosphate
Time frame: Change from baseline at 6 weeks and 12 weeks
P-25-OH-vitamin D
Time frame: Change from baseline at 6 weeks and 12 weeks
P-calcitriol
Time frame: Change from baseline at 6 weeks and 12 weeks
P-24,25-(OH)2-vitamin D
Time frame: Change from baseline at 6 weeks and 12 weeks
Vitamin D binding protein
Time frame: Change from baseline at 6 weeks and 12 weeks
Procollagen type 1 N-terminal propeptide (P1NP)
Time frame: Change from baseline at 6 weeks and 12 weeks
P-bone specific alkaline phosphatase
Time frame: Change from baseline at 6 weeks and 12 weeks
Cross-linked C-telopeptide (CTX)
Time frame: Change from baseline at 6 weeks and 12 weeks
24h U-calcium
Time frame: Change from baseline at 12 weeks
24h U-phosphate
Time frame: Change from baseline at 12 weeks
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 Jun 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, Calcium Citrate and Roux-en-Y gastric bypass in people with Roux-en-Y Gastric Bypass and Hyperparathyroidism, Secondary, run by University of Aarhus 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 4 inclusion and 7 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 Jun 2017. 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. 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?
Parathyroid Hormone (time frame: Change from baseline at 6 weeks and 12 weeks). 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 Jun 2017.