Vitamin D3 DeficiencyWeKoNCT03499327
Human Intervention Study to Increase 25-hydroxyvitamin D Levels
A study testing Wheat germ oil (UV treated) and Wheat germ oil (untreated) in people with Vitamin D3 Deficiency, run by University of Jena at 1 site in Germany.
Trial summary
The interventional study will evaluate effectiveness and potential of a regularly consumption of wheat germ oil (UV treated) vs. wheat germ oil (UV untreated) to increase plasma vitamin D levels ín humans. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D3 Deficiency
- What is being tested?
- Wheat germ oil (UV treated) and Wheat germ oil (untreated)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 5 Mar 2018to 30 Apr 2018
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects
- plasma 25(OH) vitamin D < 50 nmol/l
- nutritional habits: western diet
Who cannot join
- intake of lipid-lowering medications
- gastrointestinal diseases, diabetes mellitus type I and II
- intake of supplements (vitamin D supplements, fish oil capsules, vitamins and minerals) 3 months before and during the study
- relevant food allergies / intolerances
- visit to the solarium (within 4 weeks before beginning of the study and during the study)
- stay in the mountains / skiing (within 4 weeks before beginning of studies and during the study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Intervention Study to Increase 25-hydroxyvitamin D Levels by Regular Consumption of Wheat Germ Oil (UV-treated) vs. Wheat Germ Oil Untreated (Control)
The interventional study will evaluate effectiveness and potential of a regularly consumption of wheat germ oil (UV treated) vs. wheat germ oil (UV untreated) to increase plasma vitamin D levels ín humans.
Read the detailed description
The interventional study in parallel design will evaluate the effectiveness and potential of a daily consumption of wheat germ oil (UV treated vs. untreated) to increase plasma vitamin D levels in humans.
Wheat germ oil is naturally rich in vitamin D precursors (ergosterol and 7-dehydrocholesterol), which are converted into vitamin D2 and vitamin D3 by a defined UV light irradiation for the present study.
Half of the participants will consume UV-treated wheat germ oil (intervention) and the other part will consume traditional wheat germ oil (untreated, control). The subjects will consume 10 ml of wheat germ oil per day over an entire period of 6 weeks (no follow-up).
On the basis of the planned human intervention study (randomized, single-blind, parallel design) it will be investigated to what extent a regular consumption of wheat germ oil (UV-treated) can contribute to the increase of plasma 25 (OH) D levels.
The comparison is made against the intake of traditional (untreated) wheat germ oil (control).
The study fits with the strategy of the Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD), Halle-Jena-Leipzig, Germany (www.nutriCARD.de) and the study collaborators are active members of the nutriCARD cluster.
- Conditions
- Vitamin D3 Deficiency
- Being tested
- Wheat germ oil (UV treated), Wheat germ oil (untreated)
- Keywords
- vitamin D, ergosterol, 7-dehydro-cholesterol, wheat germ oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheat germ oil (UV treated)Dietary supplement
Wheat germ oil is naturally rich in vitamin D precursors (ergosterol and 7-dehydrocholesterol), which are converted into vitamin D2 and vitamin D3 by a defined UV light irradiation for the present study (wheat germ oil (UV treated).
The wheat germ oil (UV treated) is dispensed in dark glass bottles without label. The distinction between the groups is based on the expiration date (08.05.2018 vs. 09.05.2018). The distinction between the groups is not possible for the participants.
The daily dosage of wheat germ oil is 10 ml and the study products will be consumed over an entire period of 6 weeks (no follow-up).
Recommendation for intake: pure before a main meal.
Wheat germ oil (untreated)Dietary supplement
commercial available wheat germ oil The wheat germ oil (untreated) is dispensed in dark glass bottles without label. The distinction between the groups is based on the expiration date (08.05.2018 vs. 09.05.2018). The distinction between the groups is not possible for the participants.
The daily dosage of wheat germ oil is 10 ml and the study products will be consumed over an entire period of 6 weeks (no follow-up).
Recommendation for intake: pure before a main meal.
| Study group | Role | What they receive |
|---|---|---|
| Wheat germ oil (UV treated) | Active comparator | Wheat germ oil (UV treated) Receives: Dietary Supplement: Wheat germ oil (UV treated) |
| Wheat germ oil (untreated) | Placebo comparator | Wheat germ oil (untreated) Receives: Dietary Supplement: Wheat germ oil (untreated) |
| Control | No intervention | no study products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D status
plasma levels of 25OHD2, 25OHD3 (nmol/l)
Measured: change from baseline after 3 and 6 weeks
Secondary outcomes (10)
Blood lipids
total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (mmol/L)
Measured: change from baseline after 3 and 6 weeks
Blood glucose
fasting blood glucose (mmol/l)
Measured: change from baseline after 3 and 6 weeks
Insulin
insulin (units/ml)
Measured: change from baseline after 3 and 6 weeks
soluble Klotho (sKlotho)
sKlotho is a component of the FGF23 system and is associated with longevity
Measured: change from baseline after 3 and 6 weeks
Fibroblast growth factor 23 (FGF23)
FGF23 is a regulator of vitamin D metabolism and also a risk factor for heart failure
Measured: change from baseline after 3 and 6 weeks
Fatty acid distribution (erythrocytes)
fatty acid distribution in erythrocyte lipids (% fatty acid methyl ester)
Measured: change from baseline after 3 and 6 weeks
Vitamin D forms 1
1,25(OH)2D2 (nmol/l)
Measured: change from baseline after 3 and 6 weeks
Vitamin D forms 2
1,25(OH)2D3 (nmol/l)
Measured: change from baseline after 3 and 6 weeks
Vitamin D forms 3
24,25(OH)2D (nmol/l)
Measured: change from baseline after 3 and 6 weeks
Vitamin D forms 4
20(OH)D (nmol/l)
Measured: change from baseline after 3 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start5 Mar 2018
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D3 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
- Model description
- The randomized, single-blind human intervention study will be conducted in parallel design. Half of the participants (n = 17) will consume wheat germ oil UV-treated (intervention) and half of the participants (n = 17) will consume wheat germ oil untreated (placebo). The daily dosage of wheat germ oil is 10 ml and the study products will be consumed over an entire period of 6 weeks (no follow-up). The third group (n = 16) do not receive any study products (control).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg
- Responsible party
- Principal investigator, Christine Dawczynski,PhD, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499327
- Sponsor's protocol ID
- H5_18
- Acronym
- WeKo
- Status last verified
- Feb 2023
- First submitted
- 29 Mar 2018
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bailer AC, Philipp S, Staudt S, Weidauer T, Kiehntopf M, Lorkowski S, Stangl GI, Dawczynski C. UVB-exposed wheat germ oil increases serum 25-hydroxyvitamin D2 without improving overall vitamin D status: a randomized controlled trial. Eur J Nutr. 2022 Aug;61(5):2571-2583. doi: 10.1007/s00394-022-02827-w. Epub 2022 Feb 27.
PubMed 35220442
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Intervention Study to Increase 25-hydroxyvitamin D Levels by Regular Consumption of Wheat Germ Oil (UV-treated) vs. Wheat Germ Oil Untreated (Control)
- ClinicalTrials.gov ID
- NCT03499327
- Acronym / sponsor ID
- WeKo / H5_18
- Conditions
- Vitamin D3 Deficiency
- Keywords
- vitamin D, ergosterol, 7-dehydro-cholesterol, wheat germ oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 17 Apr 2018 (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 interventional study will evaluate effectiveness and potential of a regularly consumption of wheat germ oil (UV treated) vs. wheat germ oil (UV untreated) to increase plasma vitamin D levels ín humans.
Detailed description
The interventional study in parallel design will evaluate the effectiveness and potential of a daily consumption of wheat germ oil (UV treated vs. untreated) to increase plasma vitamin D levels in humans.
Wheat germ oil is naturally rich in vitamin D precursors (ergosterol and 7-dehydrocholesterol), which are converted into vitamin D2 and vitamin D3 by a defined UV light irradiation for the present study.
Half of the participants will consume UV-treated wheat germ oil (intervention) and the other part will consume traditional wheat germ oil (untreated, control). The subjects will consume 10 ml of wheat germ oil per day over an entire period of 6 weeks (no follow-up).
On the basis of the planned human intervention study (randomized, single-blind, parallel design) it will be investigated to what extent a regular consumption of wheat germ oil (UV-treated) can contribute to the increase of plasma 25 (OH) D levels.
The comparison is made against the intake of traditional (untreated) wheat germ oil (control).
The study fits with the strategy of the Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD), Halle-Jena-Leipzig, Germany (www.nutriCARD.de) and the study collaborators are active members of the nutriCARD cluster.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The randomized, single-blind human intervention study will be conducted in parallel design. Half of the participants (n = 17) will consume wheat germ oil UV-treated (intervention) and half of the participants (n = 17) will consume wheat germ oil untreated (placebo). The daily dosage of wheat germ oil is 10 ml and the study products will be consumed over an entire period of 6 weeks (no follow-up). The third group (n = 16) do not receive any study products (control).
| Arm | Type | Receives |
|---|---|---|
| Wheat germ oil (UV treated) | Active comparator | Dietary Supplement: Wheat germ oil (UV treated)Wheat germ oil (UV treated) |
| Wheat germ oil (untreated) | Placebo comparator | Dietary Supplement: Wheat germ oil (untreated)Wheat germ oil (untreated) |
| Control | No intervention | –no study products |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy subjects
- plasma 25(OH) vitamin D < 50 nmol/l
- nutritional habits: western diet
Key exclusion criteria (6 listed)
- intake of lipid-lowering medications
- gastrointestinal diseases, diabetes mellitus type I and II
- intake of supplements (vitamin D supplements, fish oil capsules, vitamins and minerals) 3 months before and during the study
- relevant food allergies / intolerances
- visit to the solarium (within 4 weeks before beginning of the study and during the study)
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 |
|---|---|---|
| Wheat germ oil (UV treated)Wheat germ oil is naturally rich in vitamin D precursors (ergosterol and 7-dehydrocholesterol), which are converted into vitamin D2 and vitamin D3 by a defined UV light irradiation for the present study (wheat germ oil (UV treated). The wheat germ oil (UV treated) is dispensed in dark glass bottles without label. The distinction between the groups is based on the expiration date (08.05.2018 vs. 09.05.2018). The distinction between the groups is not possible for the participants. The daily dosage of wheat germ oil is 10 ml and the study products will be consumed over an entire period of 6 weeks (no follow-up). Recommendation for intake: pure before a main meal. | Dietary supplement | Wheat germ oil (UV treated) |
| Wheat germ oil (untreated)commercial available wheat germ oil The wheat germ oil (untreated) is dispensed in dark glass bottles without label. The distinction between the groups is based on the expiration date (08.05.2018 vs. 09.05.2018). The distinction between the groups is not possible for the participants. The daily dosage of wheat germ oil is 10 ml and the study products will be consumed over an entire period of 6 weeks (no follow-up). Recommendation for intake: pure before a main meal. | Dietary supplement | Wheat germ oil (untreated) |
Primary outcome
Vitamin D status
Time frame: change from baseline after 3 and 6 weeks
plasma levels of 25OHD2, 25OHD3 (nmol/l)
10 secondary outcomes
Blood lipids
Time frame: change from baseline after 3 and 6 weeks
Blood glucose
Time frame: change from baseline after 3 and 6 weeks
Insulin
Time frame: change from baseline after 3 and 6 weeks
soluble Klotho (sKlotho)
Time frame: change from baseline after 3 and 6 weeks
Fibroblast growth factor 23 (FGF23)
Time frame: change from baseline after 3 and 6 weeks
Fatty acid distribution (erythrocytes)
Time frame: change from baseline after 3 and 6 weeks
Vitamin D forms 1
Time frame: change from baseline after 3 and 6 weeks
Vitamin D forms 2
Time frame: change from baseline after 3 and 6 weeks
Vitamin D forms 3
Time frame: change from baseline after 3 and 6 weeks
Vitamin D forms 4
Time frame: change from baseline after 3 and 6 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 Feb 2023.
- Derived from this study: PubMed 35220442Bailer AC, Philipp S, Staudt S, Weidauer T, Kiehntopf M, Lorkowski S, Stangl GI, Dawczynski C. UVB-exposed wheat germ oil increases serum 25-hydroxyvitamin D2 without improving overall vitamin D status: a randomized controlled trial. Eur J Nutr. 2022 Aug;61(5):2571-2583. doi: 10.1007/s00394-022-02827-w. Epub 2022 Feb 27.
- Study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheat germ oil (UV treated) and Wheat germ oil (untreated) in people with Vitamin D3 Deficiency, run by University of Jena at 1 site in Germany.
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 3 inclusion and 6 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 Feb 2023. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Vitamin D status (time frame: change from baseline after 3 and 6 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 NCT03499327, which also lists 1 linked publication.
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 Feb 2023; AzTrials last refreshed its copy on 30 Oct 2026.