Vitamin D DeficiencyAMORPH-DNCT07317830
Effects of Different Vitamin D3 Formulations in Vitamin D-Deficient Adults
A study testing Experimental 1 (powdered supplement) and Experimental 2 (oily supplement) in people with Vitamin D Deficiency, run by Center for Health Sciences, Serbia at 1 site in Serbia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Experimental 1 (powdered supplement) and Experimental 2 (oily supplement)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSerbia
- Study dates
- 15 Dec 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Serbia1 site, 1 recruiting
- Recruiting
Center for Health Sciences
Belgrade, 11000
Sergej M Ostojic, MD, PhD, +381-11-2643-242, sergej.ostojic@chess.edu.rs
Nikola Todorovic, PhD
About this study
Official title: The Effects of Eight Weeks of Supplementation With Two Vitamin D₃ Formulations in Adults With Subclinical and Clinical Vitamin D Deficiency: A Randomized Controlled Superiority Pilot Trial
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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Experimental 1 (powdered supplement), Experimental 2 (oily supplement)
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental 1 (powdered supplement)Dietary supplement
Active powdered ingredient (2,000 IU/d)
Experimental 2 (oily supplement)Dietary supplement
Active oily ingredient (2,000 IU/d)
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | 2,000 IU of active ingredient (powder) per day Receives: Dietary Supplement: Experimental 1 (powdered supplement) |
| Experimental 2 | Active comparator | 2,000 IU of active ingredient (oil) per day Receives: Dietary Supplement: Experimental 2 (oily supplement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
25(OH)D
Serum levels of 25(OH)D
Measured: Change from baseline 25(OH)D at 8 weeks
Secondary outcomes (4)
Total calcium
Serum levels of total calcium
Measured: Change from total calcium at 8 weeks
Ionized calcium
Serum levels of ionized calcium
Measured: Change from ionized calcium at 8 weeks
Phosphorus
Serum levels of phosphorus
Measured: Change from phosphorus at 8 weeks
Magnesium
Serum levels of magnesium
Measured: Change from magnesium at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start15 Dec 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Health Sciences, Serbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergej Ostojic, MD, PhD, Study chair, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317830
- Sponsor's protocol ID
- 302-27-01
- Acronym
- AMORPH-D
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in vitamin D. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Publications
Vieira EF, Souza S. Formulation Strategies for Improving the Stability and Bioavailability of Vitamin D-Fortified Beverages: A Review. Foods. 2022 Mar 16;11(6):847. doi: 10.3390/foods11060847.
PubMed 35327269Dalek P, Drabik D, Wolczanska H, Forys A, Jagas M, Jedruchniewicz N, Przybylo M, Witkiewicz W, Langner M. Bioavailability by design - Vitamin D3 liposomal delivery vehicles. Nanomedicine. 2022 Jul;43:102552. doi: 10.1016/j.nano.2022.102552. Epub 2022 Mar 26.
PubMed 35346834Borel P, Caillaud D, Cano NJ. Vitamin D bioavailability: state of the art. Crit Rev Food Sci Nutr. 2015;55(9):1193-205. doi: 10.1080/10408398.2012.688897.
PubMed 24915331
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Eight Weeks of Supplementation With Two Vitamin D₃ Formulations in Adults With Subclinical and Clinical Vitamin D Deficiency: A Randomized Controlled Superiority Pilot Trial
- ClinicalTrials.gov ID
- NCT07317830
- Acronym / sponsor ID
- AMORPH-D / 302-27-01
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Center for Health Sciences, SerbiaUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Dietary Supplement: Experimental 1 (powdered supplement)2,000 IU of active ingredient (powder) per day |
| Experimental 2 | Active comparator | Dietary Supplement: Experimental 2 (oily supplement)2,000 IU of active ingredient (oil) per day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental 1 (powdered supplement)Active powdered ingredient (2,000 IU/d) | Dietary supplement | Experimental 1 |
| Experimental 2 (oily supplement)Active oily ingredient (2,000 IU/d) | Dietary supplement | Experimental 2 |
Primary outcome
25(OH)D
Time frame: Change from baseline 25(OH)D at 8 weeks
Serum levels of 25(OH)D
4 secondary outcomes
Total calcium
Time frame: Change from total calcium at 8 weeks
Ionized calcium
Time frame: Change from ionized calcium at 8 weeks
Phosphorus
Time frame: Change from phosphorus at 8 weeks
Magnesium
Time frame: Change from magnesium at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Background: PubMed 35327269Vieira EF, Souza S. Formulation Strategies for Improving the Stability and Bioavailability of Vitamin D-Fortified Beverages: A Review. Foods. 2022 Mar 16;11(6):847. doi: 10.3390/foods11060847.
- Background: PubMed 35346834Dalek P, Drabik D, Wolczanska H, Forys A, Jagas M, Jedruchniewicz N, Przybylo M, Witkiewicz W, Langner M. Bioavailability by design - Vitamin D3 liposomal delivery vehicles. Nanomedicine. 2022 Jul;43:102552. doi: 10.1016/j.nano.2022.102552. Epub 2022 Mar 26.
- Background: PubMed 24915331Borel P, Caillaud D, Cano NJ. Vitamin D bioavailability: state of the art. Crit Rev Food Sci Nutr. 2015;55(9):1193-205. doi: 10.1080/10408398.2012.688897.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in vitamin D. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sergej Ostojic, MD, PhD study chair
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental 1 (powdered supplement) and Experimental 2 (oily supplement) in people with Vitamin D Deficiency, run by Center for Health Sciences, Serbia at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergej Ostojic, MD, PhD (+381112643242, sergej.ostojic@chess.edu.rs), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
25(OH)D (time frame: Change from baseline 25(OH)D at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07317830, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.