Effects of Different Vitamin D3 Formulations in Vitamin D-Deficient Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-06-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Experimental 1

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

Group Type EXPERIMENTAL

Experimental 1 (powdered supplement)

Intervention Type DIETARY_SUPPLEMENT

Active powdered ingredient (2,000 IU/d)

Experimental 2

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

Group Type ACTIVE_COMPARATOR

Experimental 2 (oily supplement)

Intervention Type DIETARY_SUPPLEMENT

Active oily ingredient (2,000 IU/d)

Interventions

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Experimental 1 (powdered supplement)

Active powdered ingredient (2,000 IU/d)

Intervention Type DIETARY_SUPPLEMENT

Experimental 2 (oily supplement)

Active oily ingredient (2,000 IU/d)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes