IMPACT OF VITAMIN D SUPPLEMENTATION ON SKELETAL AND NON SKELETAL MANIFESTATIONS IN PATIENTS WITH PRIMARY HYPERPARATHYROIDISM SUBMITTED TO PARATHYROIDECTOMY OR FOLLOWED WITHOUT SURGERY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005027-16-IT

Enrollment

300

Registered

2014-06-17

Start date

2015-09-24

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

PRIMARY HYPERPARATHYROIDISM MedDRA version: 20.0 Level: LLT Classification code 10036693 Term: Primary hyperparathyroidism System Organ Class: 100000004860

Interventions

Trade Name: DIBASE Product Name: COLECALCIFEROLO (VITAMINA D3) Pharmaceutical Form: Oral drops, solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Postmenopausal female PHPT patients aged 45-80 years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120

Exclusion criteria

Exclusion criteria: familial forms of PHPT; serum calcium above 12.5 mg/dL; malignancy other than nonmelanoma skin cancer, diseases or medications known to affect mineral metabolism

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate if normal and/or high VitD3 supplementation vs no supplementation could affect the complications of PHPT in two different groups of postmenopausal patients: a)asymptomatic PHPT patients (subjects not fulfilling the surgical criteria plus osteoporosis); b)symptomatic PHPT patients that are undergoing parathyroidectomy; The end points are: - the variation of Bone Mineral Density (BMD) measured at lumbar spine / femoral neck / forearm ;Secondary Objective: - number of falls - clinical and morphometric vertebral fractures - quality of life and neuropsychological aspects - lipids and glucose metabolism - cardiac and vascular damage (diastolic dysfunction, left ventricular hypertrophy, cardiac calcium deposits in the myocardium, aortic and mitral valve calcification + carotid intima-media thickness + the presence of carotid plaque + the percent of carotid stenosis) - renal function. Finally measurement of Vitamin D Binding Protein (DBP) and the analysis of polymorphic variants of GC CYP2R1 CYP24A1 genes that could influence the effect of vitamin D supplementation, affecting the circulating levels of vitamin D, will be performed. ;Primary end point(s): To evaluate if normal and/or high VitD3 supplementation vs no supplementation could affect the variation of Bone Mineral Density (BMD) measured at lumbar spine / femoral neck / forearm;Timepoint(s) of evaluation of this end point: BASALINE, 12 MONTHS, 24 MONTHS	—

Measure

Time frame

Main Objective: To evaluate if normal and/or high VitD3 supplementation vs no supplementation could affect the complications of PHPT in two different groups of postmenopausal patients: a)asymptomatic PHPT patients (subjects not fulfilling the surgical criteria plus osteoporosis); b)symptomatic PHPT patients that are undergoing parathyroidectomy; The end points are: - the variation of Bone Mineral Density (BMD) measured at lumbar spine / femoral neck / forearm ;Secondary Objective: - number of falls - clinical and morphometric vertebral fractures - quality of life and neuropsychological aspects - lipids and glucose metabolism - cardiac and vascular damage (diastolic dysfunction, left ventricular hypertrophy, cardiac calcium deposits in the myocardium, aortic and mitral valve calcification + carotid intima-media thickness + the presence of carotid plaque + the percent of carotid stenosis) - renal function. Finally measurement of Vitamin D Binding Protein (DBP) and the analysis of polymorphic variants of GC CYP2R1 CYP24A1 genes that could influence the effect of vitamin D supplementation, affecting the circulating levels of vitamin D, will be performed. ;Primary end point(s): To evaluate if normal and/or high VitD3 supplementation vs no supplementation could affect the variation of Bone Mineral Density (BMD) measured at lumbar spine / femoral neck / forearm;Timepoint(s) of evaluation of this end point: BASALINE, 12 MONTHS, 24 MONTHS

—

Secondary

Measure	Time frame
Secondary end point(s): To evaluate if normal and/or high VitD3 supplementation vs no supplementation could affect in the two groups of patients: - number of falls - clinical and morphometric vertebral fractures - quality of life and neuropsychological aspects - lipids and glucose metabolism - cardiac and vascular damage (diastolic dysfunction, left ventricular hypertrophy, cardiac calcium deposits in the myocardium, aortic and mitral valve calcification + carotid intima-media thickness + the presence of carotid plaque + the percent of carotid stenosis) - renal function. - Vitamin D Binding Protein (DBP) and that could together with the analysis of polymorphic variants of GC CYP2R1 CYP24A1 genes influence the effect of vitamin D supplementation, affecting the circulating levels of vitamin D ;Timepoint(s) of evaluation of this end point: BASALINE, 12 MONTHS, 24 MONTHS	—

Measure

Time frame

Secondary end point(s): To evaluate if normal and/or high VitD3 supplementation vs no supplementation could affect in the two groups of patients: - number of falls - clinical and morphometric vertebral fractures - quality of life and neuropsychological aspects - lipids and glucose metabolism - cardiac and vascular damage (diastolic dysfunction, left ventricular hypertrophy, cardiac calcium deposits in the myocardium, aortic and mitral valve calcification + carotid intima-media thickness + the presence of carotid plaque + the percent of carotid stenosis) - renal function. - Vitamin D Binding Protein (DBP) and that could together with the analysis of polymorphic variants of GC CYP2R1 CYP24A1 genes influence the effect of vitamin D supplementation, affecting the circulating levels of vitamin D ;Timepoint(s) of evaluation of this end point: BASALINE, 12 MONTHS, 24 MONTHS

—

Countries

Italy

Contacts

Public ContactANNAMARIA CIACCIO

CASA SOLLIEVO DELLA SOFFERENZA IRCCS

comitatoetico@operapadrepio.it00390882410831

Outcome results

None listed

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