Effects of Different Vitamin D3 Formulations in Vitamin D-Deficient Adults (AMORPH-D)

Center for Health Sciences, Serbia

Status: Enrolling

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: Experimental 1 (powdered supplement); Dietary Supplement: Experimental 2 (oily supplement)

Study type: Interventional

Funder types: Other

Identifiers

NCT07317830

302-27-01

Details and patient eligibility

About

This randomized controlled superiority pilot trial will evaluate the efficacy of two vitamin D3 formulations administered over eight weeks in adults with subclinical or clinical vitamin D deficiency. The study will compare changes in serum 25-hydroxyvitamin D concentrations between formulations, as well as the proportion of participants who will achieve vitamin D sufficiency. Both formulations are expected to improve vitamin D status, with the hypothesis that one formulation will demonstrate superior bioavailability, resulting in greater and faster increases in circulating 25-hydroxyvitamin D. The findings will provide preliminary evidence to inform formulation selection and dosing strategies for correcting vitamin D deficiency and will support the design of larger, confirmatory trials.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults aged 18 years and over
• Serum 25(OH)D < 75 nmol/L
• BMI 18.5 - 29.9 kg/m2
• Free of clinically significant acute disorders and severe chronic diseases
• No planned travel to high-UV destinations or tanning bed use during the trial
• Willing to avoid non-study vitamin D supplements
• Able to give written informed consent and comply with study visits
• Submitted informed consent

Exclusion criteria

• Pregnancy of breast feeding
• Underweight or obesity
• History of any dietary supplement use within 8 weeks before screening
• Medications that materially alter vitamin D metabolism or calcium balance
• Subjects with a history of medicine or alcohol abuse
• Abnormal values for lab clinical chemistry (> 2 SD)
• Unwillingness to return for follow-up analysis
• Participation in other clinical trials within 60 days prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Experimental 1

Experimental group

Description:

2,000 IU of active ingredient (powder) per day

Treatment:

Dietary Supplement: Experimental 1 (powdered supplement)

Experimental 2

Active Comparator group

Description:

2,000 IU of active ingredient (oil) per day

Treatment:

Dietary Supplement: Experimental 2 (oily supplement)