NCT02830789

Brief 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. The study will be double blinded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

July 6, 2016

Last Update Submit

June 23, 2017

Conditions

Roux-en-Y Gastric BypassHyperparathyroidism, Secondary

Outcome Measures

Primary Outcomes (1)

  • Parathyroid Hormone

    Change from baseline at 6 weeks and 12 weeks

Secondary Outcomes (12)

  • Se-ion-calcium

    Change from baseline at 6 weeks and 12 weeks

  • P-magnesium

    Change from baseline at 6 weeks and 12 weeks

  • P-phosphate

    Change from baseline at 6 weeks and 12 weeks

  • P-25-OH-vitamin D

    Change from baseline at 6 weeks and 12 weeks

  • P-calcitriol

    Change from baseline at 6 weeks and 12 weeks

  • +7 more secondary outcomes

Study Arms (2)

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

Dietary Supplement: Calcium CarbonateDietary Supplement: PlaceboProcedure: 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

Dietary Supplement: Calcium CitrateProcedure: Roux-en-Y gastric bypass

Interventions

Calcium CarbonateDIETARY_SUPPLEMENT
Also known as: Unikalk Forte
Calcium Carbonate
Calcium CitrateDIETARY_SUPPLEMENT
Also known as: Unikalk Citrat
Calcium Citrate
PlaceboDIETARY_SUPPLEMENT

Tablet manufactured to mimic a calcium carbonate tablet

Calcium Carbonate
Roux-en-Y gastric bypassPROCEDURE

Roux-en-Y gastric bypass surgery at least 12 months before study inclusion

Calcium CarbonateCalcium Citrate

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Liver disease
  • Renal disease
  • Hypercalcemia
  • Untreated thyroid disease
  • Parathyroid disease except secondary hyperparathyroidism
  • abusing alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Enodocrinology and Internal Medicine, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

Calcium CarbonateCalcium CitrateGastric Bypass

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMineralsCitric AcidCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student, MD

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 13, 2016

Study Start

December 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

June 26, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)