Non-inferiority RCT on Fish Waste-Derived vs. Synthetic Vitamin D Supplementation in Healthy Adults With Suboptimal Vitamin D Levels

Launched by UNIVERSITY OF BOLOGNA · Aug 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether vitamin D supplements made from fish waste are just as effective as the usual synthetic (man-made) vitamin D supplements in raising vitamin D levels in healthy adults who have slightly low vitamin D. Vitamin D is important for strong bones, muscles, and overall health, and many people don’t get enough of it. The study will give participants a daily dose of 600 IU of vitamin D—either from fish-derived sources or synthetic supplements—and compare how well each type raises vitamin D levels in the blood.

To join the study, you need to be between 18 and 60 years old and have vitamin D levels that are low but not severely deficient (between 20 and 40 ng/mL in the blood). You should be generally healthy without certain bone diseases or kidney problems, and not currently taking other vitamin D supplements or certain medications. If you take part, you will be asked to follow the study rules and attend check-ups to measure your vitamin D levels. This study is important because it explores a natural and environmentally friendly way to produce vitamin D supplements, which could offer a sustainable alternative to synthetic options in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female aged ≥ 18 years and ≤ 60 years old
• • Vitamin D plasma level between 20 and 40 ng/mL
• • Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements
• • Subjects agree to participate in the study and having dated and signed the informed consent form
• Exclusion Criteria:
• • Intake of dietary supplements or drugs containing Vitamin D
• • Diagnosis of osteopenia/osteoporosis, rheumatological diseases, history of non-traumatic bone fractures
• • Known diagnosis of hyperparathyroidism, hypercalcemia, severe renal failure (eGFR\<30 mg/dL) Known intolerance or allergy to fish or fish derived products
• • Any preventive treatments (i.e. hypocholesterolemics, antihypertensives) not stabilized in type and dose for at least 3 months
• • Active pregnancy or lactation
• • Any medical or surgical condition that would limit the patient adhesion to the study protocol