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Study to evaluate the safety and efficacy of CitrokalciumD 300mg/300 NE tablets for supplementation in patients with calcium and vitamin D deficiency conditions.

Open label multicentric study to evalute the safety and efficacy of CitrokalciumD 300 mg/300 NE tablets in patients assessed deficiency for supplementation of calcium and vitamin D. - Study to evaluate the safety and efficacy of the combination of calciumcitrate and vitamin D

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-001267-23-HU
Enrollment
Unknown
Registered
2013-04-08
Start date
2013-06-19
Completion date
Unknown
Last updated
2014-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D and calcium deficiency MedDRA version: 16.0 Level: PT Classification code 10006956 Term: Calcium deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 16.0 Level: PT Classification code 10047626 Term: Vitamin D deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: CitrokalciumD 300 mg/300 NE Product Code: CitrokalciumD 300 Pharmaceutical Form: Tablet INN or Proposed INN: citrokalcium CAS Number: 813-94-5 Current Sponsor code: citrocalcium-300 Ot

Sponsors

Pharma Patent Kft
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - postmenopausal women in age of 40-70 - 25(OH)-D szint =65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: - hypercalcaemia/ se Ca levels out of 2.20-2.60 mmol/L range - or anamnestic or renal disorder of calcium hoemostatis that may interfere with the treatment - other calcium of vitamin D therapy with the last 2 month over certain limits of dosages

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the safety of the combined treatment of calcium and vitamin D supplementation by fix combination of calciumcitrate 300 mg/ 300 NE vitamin D tablets in patients assessed deficiency and required supplementation, via registration of related side effects and frequency;Secondary Objective: To evaluate the efficacy of combined treatment of vitamin D and calcium through the assessments of the calcitropic hormones, BSAP, and via parameters of calcium homeostasis compared to base period. ;Primary end point(s): Safety parameters assessed via adverse events associated with treatment by type and frequency compared to base period. ;Timepoint(s) of evaluation of this end point: 84+/-8 days—

Secondary

MeasureTime frame
Secondary end point(s): The assessment of efficacy of the treatment with calcium-citrate 300 mg/ 300 NE vitamin D tablets by the parameters of the calcium homeostasis (se Ca) and calciotrop (surrogate) parameters (PTH, 25(OH)-D, BSAP) compared to base. ;Timepoint(s) of evaluation of this end point: 84+/-8 days—

Countries

Hungary

Contacts

Public ContactIroda-törzskönyvezés

Pharma Patent Kft

clinical@pharmapatent.hu361630 6182

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026