Vitamin D deficiency: a diagnosis often missed.
Colin Paterson
https://pubmed.ncbi.nlm.nih.gov/21841591Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06138249
Different Kinds of Vitamin D Intake and Its Metabolites: Blood Levels and Bone Mineral Density. A Randomized Clinical Trial.
Led by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Updated on 2025-11-25
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Lead Sponsor
S
Silvana De Giorgi
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adults with hypovitaminosis D, a condition characterized by low vitamin D levels in the blood. This randomized clinical trial compares three different ways of taking vitamin D supplements to see how well they raise vitamin D levels and affect bone mineral density. The purpose is to find the best dosing method for improving vitamin D intake. Participants are assigned to one of three treatment groups: Group A receives 0.266 mg of calcifediol once a month, Group B takes 25,000 IU of cholecalciferol every 15 days, and Group C uses 4 drops of calcifediol daily. Vitamin D blood levels are measured after one month of treatment to guide dosing. The study also monitors bone mineral density over an 18-month period. During the trial, participants have their vitamin D levels checked at one and six months after starting treatment. Bone density is assessed using DEXA scans between recruitment and 18 months. The study involves randomization and single masking to monitor and compare the effects of these vitamin D supplementation methods. Participation lasts up to 18 months, including follow-up assessments.
CONDITIONS
Brief Title
Cholecalciferol and Calcifediol Are Both Useful to Improve Vitamin D Serum Levels
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Diagnosed with hypovitaminosis D (vitamin D level below 20 ng/mL)
You will not qualify if you...
- Osteoporosis with a T score below -2.5 SD
- Presence of kidney or liver diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants receive assigned Vitamin D supplements as treatment to improve vitamin D serum levels.
Monthly visits for up to 6 months
Follow-up
Duration - Up to 18 months after recruitment
Participants are monitored to assess bone mineral density changes after treatment completion.
Periodic visits up to 18 months
Trial Site Locations
Total: 1 location
1
University of Bari
Bari, Italy, 70124
Actively Recruiting
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Research Team
S
Silvana De Giorgi, AP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
25(OH)Vitamin D Deficiency and Calcifediol Treatment in Pediatrics.
Luis Castano, Leire Madariaga, Gema Grau...
https://pubmed.ncbi.nlm.nih.gov/35565821Vitamin D and rickets: much has been accomplished, but there is room for improvement.
James E Haddow
https://pubmed.ncbi.nlm.nih.gov/21852696