AtherosclerosisDOSFEMNCT01967459
Effects Vitamin D Suppletion on Postprandial Leukocyte Activation
A study testing Cholecalciferol in people with Atherosclerosis and Oxidative Stress, run by Sint Franciscus Gasthuis at 1 site in Netherlands.
Trial summary
Administration of vitamin D will have a beneficial effect on postprandial leukocyte activation, oxidative stress and arterial stiffness in vitamin D deficient females. High doses of vitamin D may have a more pronounced effect than low doses. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Oxidative Stress, Leukocyte Activation Disorder
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2013to Dec 2015
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of 18 years or older;
- Pre-menopausal;
- BMI ≥25.0 kg/m2;
- Vitamin D deficiency, defined by a 25-hydroxyvitamin D level of <30ng/ml;
- Use of oral contraceptives.
Who cannot join
- The use of any kind of medication except oral contraceptives;
- Smoking;
- Pregnancy;
- Participation in a clinical study less than 6 months before inclusion;
- The use of (multi)vitamin supplements.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Sint Franciscus Gasthuis
Rotterdam, South Holland, 3045 PM
About this study
Official title: Effects of High and Low Dose Vitamin D Suppletion on Postprandial Leukocyte Activation, Oxidative Stress and Vascular Function in Healthy Overweight and Obese Females
Administration of vitamin D will have a beneficial effect on postprandial leukocyte activation, oxidative stress and arterial stiffness in vitamin D deficient females. High doses of vitamin D may have a more pronounced effect than low doses.
Read the detailed description
Rationale: Postprandial lipemia, known to be associated with acute leukocyte activation, impairs endothelial function and promotes atherosclerosis. Deficiency of vitamin D is associated with increased cardiovascular risk, but the precise mechanism is still unclear. A recent pilot study performed in our laboratory showed improved postprandial vascular function by pulse wave analysis and decreased postprandial leukocyte activation after vitamin D supplementation. Interestingly, the effects on leukocyte activation were solely found in females.
Hypothesis: The beneficial effects of vitamin D administration on postprandial leukocyte activation are mediated by suppression of oxidative stress. High doses of vitamin D may have a more pronounced effect than low doses.
Objective: To estimate the effect sizes of different doses of vitamin D on postprandial leukocyte activation markers, oxidative stress and arterial stiffness in vitamin D deficient females.
Study design: Randomized, double blind pilot study. Study population: Premenopausal overweight and obese female volunteers with proven vitamin D deficiency, ≥ 18 years of age.
Intervention: Two oral fat load tests (OFLTs) will be performed. After the first OFLT, volunteers will be randomly assigned to receive a single low dose (75 000 IU) or high dose (300 000 IU) of cholecalciferol drink. One week later the OFLT will be repeated.
Main study parameters/endpoints: Postprandial leukocyte activation, oxidative stress parameters and arterial augmentation index.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The use of a single dose of 300 000 IU of cholecalciferol has been established to be a safe and effective way to correct vitamin D deficiency. Volunteers will be hospitalized on 2 different days (day 1, day 8) for approximately nine hours each day and receive an oral fat load. Cholecalciferol will be administered once. Volunteers will be instructed not to take vitamin D supplements during the study up until 3 months after the study. The volunteers' general practitioner will be informed on their participation. A total of 222ml (111ml for each postprandial test) of blood will be drawn. Volunteers will be allowed to drink only water during the tests. There is a theoretical risk of hypercalcemia but no excessive risk is involved. Volunteers receive 250 euros for full participation. Furthermore, volunteers will be told and given advice if they turn out to suffer from hyperlipidemia or any other condition.
- Being tested
- Cholecalciferol
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called D-cura
Single dose D-cura cholecalciferol drink 100 000 IU/ml, in total 300 000 IU (=3ml)
CholecalciferolDrug
Also called D-cura
Single dose D-cura cholecalciferol drink 250 000 IU/ml, in total 75 000 IU (=3ml)
| Study group | Role | What they receive |
|---|---|---|
| High dose vitamin D | Active comparator | Volunteers assigned to this arm will receive a single dose of oral cholecalciferol 300 000 IU, in the form of 3 ml D-cura drink 100 000 IU/ml Receives: Drug: Cholecalciferol |
| Low dose vitamin D | Active comparator | Volunteers assigned to this arm will receive a single dose of oral cholecalciferol 75000 IU, in the form of 3 ml D-cura drink 25 000 IU/ml Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of vitamin D on leukocyte cluster of differentiation antigen 11b expression
the differential effect of 75 000 IU low dose vs. 300 000 IU high dose vitamin D on postprandial leukocyte activation markers cluster of differentiation antigen 11b
Measured: 2, 4, 6 and 8 hours postprandial
Secondary outcomes (2)
Effect of vitamin D on oxidative stress
the differential effect of 75 000 IU low dose vs. 300 000 IU high dose vitamin D on oxidative stress
Measured: 2,4,6 and 8 hours postprandial
Effect of vitamin D on vascular function
the differential effect of 75 000 IU low dose vs. 300 000 IU high dose vitamin D on vascular function (Pulse Wave Velocity and Augmentation Index)
Measured: 0,2,6,8 and 8 hours postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sint Franciscus Gasthuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.A. de Vries, Sint Franciscus Gasthuis
- Investigators
- Manuel Castro Cabezas, MD, PhD, Study chair, Sint Franciscus Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967459
- Sponsor's protocol ID
- NL44804.101.13
- Acronym
- DOSFEM
- Status last verified
- Oct 2017
- First submitted
- 17 Oct 2013
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High and Low Dose Vitamin D Suppletion on Postprandial Leukocyte Activation, Oxidative Stress and Vascular Function in Healthy Overweight and Obese Females
- ClinicalTrials.gov ID
- NCT01967459
- Acronym / sponsor ID
- DOSFEM / NL44804.101.13
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sint Franciscus GasthuisUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Oct 2013 (estimated)
- 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.
Administration of vitamin D will have a beneficial effect on postprandial leukocyte activation, oxidative stress and arterial stiffness in vitamin D deficient females. High doses of vitamin D may have a more pronounced effect than low doses.
Detailed description
Rationale: Postprandial lipemia, known to be associated with acute leukocyte activation, impairs endothelial function and promotes atherosclerosis. Deficiency of vitamin D is associated with increased cardiovascular risk, but the precise mechanism is still unclear. A recent pilot study performed in our laboratory showed improved postprandial vascular function by pulse wave analysis and decreased postprandial leukocyte activation after vitamin D supplementation. Interestingly, the effects on leukocyte activation were solely found in females.
Hypothesis: The beneficial effects of vitamin D administration on postprandial leukocyte activation are mediated by suppression of oxidative stress. High doses of vitamin D may have a more pronounced effect than low doses.
Objective: To estimate the effect sizes of different doses of vitamin D on postprandial leukocyte activation markers, oxidative stress and arterial stiffness in vitamin D deficient females.
Study design: Randomized, double blind pilot study. Study population: Premenopausal overweight and obese female volunteers with proven vitamin D deficiency, ≥ 18 years of age.
Intervention: Two oral fat load tests (OFLTs) will be performed. After the first OFLT, volunteers will be randomly assigned to receive a single low dose (75 000 IU) or high dose (300 000 IU) of cholecalciferol drink. One week later the OFLT will be repeated.
Main study parameters/endpoints: Postprandial leukocyte activation, oxidative stress parameters and arterial augmentation index.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The use of a single dose of 300 000 IU of cholecalciferol has been established to be a safe and effective way to correct vitamin D deficiency. Volunteers will be hospitalized on 2 different days (day 1, day 8) for approximately nine hours each day and receive an oral fat load. Cholecalciferol will be administered once. Volunteers will be instructed not to take vitamin D supplements during the study up until 3 months after the study. The volunteers' general practitioner will be informed on their participation. A total of 222ml (111ml for each postprandial test) of blood will be drawn. Volunteers will be allowed to drink only water during the tests. There is a theoretical risk of hypercalcemia but no excessive risk is involved. Volunteers receive 250 euros for full participation. Furthermore, volunteers will be told and given advice if they turn out to suffer from hyperlipidemia or any other condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose vitamin D | Active comparator | Drug: CholecalciferolVolunteers assigned to this arm will receive a single dose of oral cholecalciferol 300 000 IU, in the form of 3 ml D-cura drink 100 000 IU/ml |
| Low dose vitamin D | Active comparator | Drug: CholecalciferolVolunteers assigned to this arm will receive a single dose of oral cholecalciferol 75000 IU, in the form of 3 ml D-cura drink 25 000 IU/ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of 18 years or older;
- Pre-menopausal;
- BMI ≥25.0 kg/m2;
- Vitamin D deficiency, defined by a 25-hydroxyvitamin D level of <30ng/ml;
- Use of oral contraceptives.
Key exclusion criteria (5 listed)
- The use of any kind of medication except oral contraceptives;
- Smoking;
- Pregnancy;
- Participation in a clinical study less than 6 months before inclusion;
- The use of (multi)vitamin supplements.
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 |
|---|---|---|
| CholecalciferolAlso: D-curaSingle dose D-cura cholecalciferol drink 100 000 IU/ml, in total 300 000 IU (=3ml) | Drug | High dose vitamin D |
| CholecalciferolAlso: D-curaSingle dose D-cura cholecalciferol drink 250 000 IU/ml, in total 75 000 IU (=3ml) | Drug | Low dose vitamin D |
Primary outcome
effect of vitamin D on leukocyte cluster of differentiation antigen 11b expression
Time frame: 2, 4, 6 and 8 hours postprandial
the differential effect of 75 000 IU low dose vs. 300 000 IU high dose vitamin D on postprandial leukocyte activation markers cluster of differentiation antigen 11b
2 secondary outcomes
Effect of vitamin D on oxidative stress
Time frame: 2,4,6 and 8 hours postprandial
Effect of vitamin D on vascular function
Time frame: 0,2,6,8 and 8 hours postprandial
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 5 Oct 2017.
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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.
Manuel Castro Cabezas, MD, PhD study chair
Sint Franciscus Gasthuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol in people with Atherosclerosis and Oxidative Stress, run by Sint Franciscus Gasthuis at 1 site in Netherlands.
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 5 inclusion and 5 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 5 Oct 2017. 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 Netherlands. 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?
effect of vitamin D on leukocyte cluster of differentiation antigen 11b expression (time frame: 2, 4, 6 and 8 hours postprandial). 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 5 Oct 2017.