Vitamin D DeficiencyVITAD/2NCT03810261
Challenges in Achieving Adequate Vitamin D Status in the Adult Population/ Part 2
A study testing Oil-based vitamin D, Water-based vitamin D and Vitamin D capsules in people with Vitamin D Deficiency, run by Institute of Nutrition, Slovenia (Nutris) at 1 site in Slovenia.
Trial summary
The efficiency of different vitamin D formulations in treating suboptimal vitamin D status in adult population will be determined. It will provide insights into the influence of formulation on vitamin D absorption. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Oil-based vitamin D, Water-based vitamin D and Vitamin D capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSlovenia
- Study dates
- 8 Jan 2019to 2 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- vitamin D suboptimal status
- Signed Informed consent form (ICF),
- Caucasian race
- Age between 18 and 65 years at the time of the signature of Informed consent form (ICF),
- Willingness to avoid a consumption of any food supplements containing Vitamin D during the study, except the ones prescribed by the study researchers, and to avoid use of solarium or other artificial UVB sources
- Willingness to follow all study procedures
Who cannot join
- Pregnancy or breastfeeding,
- Known or suspected allergy to any ingredient of the tested products in Part 2,
- Pronounced avoidance of sunshine (eg reporting of allergy to the sun)
- Use of food supplements containing Vitamin D or fish oil or omega 3 fatty acids in last three months prior to inclusion,
- Special dietary habits used by a small part of the population (veganism, low-carb high-fat (LCHF) diet, caloric restriction diet, note: vegetarians are not excluded)
- Diets prescribed by the medical profession
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- Disorders of the kidneys, thyroid, digestive tract, osteoporosis and other bone diseases, skin diseases
- Other diseases and conditions that affect the absorption and synthesis of vitamin D
- Exposure to stronger sunlight in the last three months prior to engaging in a survey (travel to countries with stronger sunshine, use of solarium),
- The consumption of margarine or plant substitutes for milk / milk products several times a day, as these foods are most often enriched with vitamin D,
- Visiting the solarium in the last three months before joining the survey,
- Mental incapacity that precludes adequate understanding or cooperation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 2
The efficiency of different vitamin D formulations in treating suboptimal vitamin D status in adult population will be determined. It will provide insights into the influence of formulation on vitamin D absorption.
A randomised controlled intervention trial will be conducted on at least 72 subjects (18-65 years) with suboptimal Vitamin D status. Subjects will be selected from a pool of subjects in Part 1 of the study, after completion of winter sampling.
Study subjects will be randomised into four study groups (at least 18 subjects per study group). Three different treatments will be compared with a control group, which will not receive any supplemental Vitamin D. The three tested Vitamin D preparations in the treatment groups will be (A) oil-based VALENS vitamin D; (B) water-based VALENS vitamin D; and (C) Vitamin D capsules with starch-adsorbed vitamin D (powder). All these products are commercially available. Prior to study, actual level of vitamin D will be determined using appropriate analytical method. The treatment will be with 1000 IU Vitamin D per day, for two months, in all three groups. Second serum vitamin D level will be determined on last day of the treatment, and compared with pre-treatment vitamin D level.
- Conditions
- Vitamin D Deficiency
- Being tested
- Oil-based vitamin D, Water-based vitamin D, Vitamin D capsules
- 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.
Oil-based vitamin DDietary supplement
Participants will receive oil-based VALENS vitamin D, 1000 IU/day for 8 weeks.
Water-based vitamin DDietary supplement
Participants will receive water-based VALENS vitamin D, 1000 IU/day for 8 weeks.
Vitamin D capsulesDietary supplement
Participants will receive vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Oil-based vitamin D group | Experimental | Oil-based vitamin D, 1000 IU/day for 8 weeks Receives: Dietary Supplement: Oil-based vitamin D |
| Water-based vitamin D group | Experimental | Water-based vitamin D, 1000 IU/day for 8 weeks Receives: Dietary Supplement: Water-based vitamin D |
| Vitamin D capsules group | Experimental | Vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks Receives: Dietary Supplement: Vitamin D capsules |
| Control group | No intervention | This group will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vitamin D serum concentration after 8 weeks of supplementation
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start8 Jan 2019
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)
- Sponsor type
- University, hospital or other
- Collaborators
- VIST - Faculty of Applied Sciences, Slovenian Research Agency, Valens Int. d.o.o., Slovenija
- Responsible party
- Sponsor
- Investigators
- Katja Žmitek, PhD, Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810261
- Sponsor's protocol ID
- VITAD-01-2018 Part 2
- Acronym
- VITAD/2
- Status last verified
- Jun 2021
- First submitted
- 17 Jan 2019
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 2
- ClinicalTrials.gov ID
- NCT03810261
- Acronym / sponsor ID
- VITAD/2 / VITAD-01-2018 Part 2
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)University, hospital or other
- Collaborators
- VIST - Faculty of Applied Sciences, Slovenian Research Agency, Valens Int. d.o.o., Slovenija
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 18 Jan 2019 (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.
The efficiency of different vitamin D formulations in treating suboptimal vitamin D status in adult population will be determined. It will provide insights into the influence of formulation on vitamin D absorption.
A randomised controlled intervention trial will be conducted on at least 72 subjects (18-65 years) with suboptimal Vitamin D status. Subjects will be selected from a pool of subjects in Part 1 of the study, after completion of winter sampling.
Study subjects will be randomised into four study groups (at least 18 subjects per study group). Three different treatments will be compared with a control group, which will not receive any supplemental Vitamin D. The three tested Vitamin D preparations in the treatment groups will be (A) oil-based VALENS vitamin D; (B) water-based VALENS vitamin D; and (C) Vitamin D capsules with starch-adsorbed vitamin D (powder). All these products are commercially available. Prior to study, actual level of vitamin D will be determined using appropriate analytical method. The treatment will be with 1000 IU Vitamin D per day, for two months, in all three groups. Second serum vitamin D level will be determined on last day of the treatment, and compared with pre-treatment vitamin D level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oil-based vitamin D group | Experimental | Dietary Supplement: Oil-based vitamin DOil-based vitamin D, 1000 IU/day for 8 weeks |
| Water-based vitamin D group | Experimental | Dietary Supplement: Water-based vitamin DWater-based vitamin D, 1000 IU/day for 8 weeks |
| Vitamin D capsules group | Experimental | Dietary Supplement: Vitamin D capsulesVitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks |
| Control group | No intervention | –This group will receive no intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- vitamin D suboptimal status
- Signed Informed consent form (ICF),
- Caucasian race
- Age between 18 and 65 years at the time of the signature of Informed consent form (ICF),
- Willingness to avoid a consumption of any food supplements containing Vitamin D during the study, except the ones prescribed by the study researchers, and to avoid use of solarium or other artificial UVB sources
Key exclusion criteria (12 listed)
- Pregnancy or breastfeeding,
- Known or suspected allergy to any ingredient of the tested products in Part 2,
- Pronounced avoidance of sunshine (eg reporting of allergy to the sun)
- Use of food supplements containing Vitamin D or fish oil or omega 3 fatty acids in last three months prior to inclusion,
- Special dietary habits used by a small part of the population (veganism, low-carb high-fat (LCHF) diet, caloric restriction diet, note: vegetarians are not excluded)
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 |
|---|---|---|
| Oil-based vitamin DParticipants will receive oil-based VALENS vitamin D, 1000 IU/day for 8 weeks. | Dietary supplement | Oil-based vitamin D group |
| Water-based vitamin DParticipants will receive water-based VALENS vitamin D, 1000 IU/day for 8 weeks. | Dietary supplement | Water-based vitamin D group |
| Vitamin D capsulesParticipants will receive vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks. | Dietary supplement | Vitamin D capsules group |
Primary outcome
Change in vitamin D serum concentration after 8 weeks of supplementation
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Katja Žmitek, PhD principal investigator
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oil-based vitamin D, Water-based vitamin D and Vitamin D capsules in people with Vitamin D Deficiency, run by Institute of Nutrition, Slovenia (Nutris) at 1 site in Slovenia.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 22 Jun 2021. 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 Slovenia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vitamin D serum concentration after 8 weeks of supplementation (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2021.