- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02860663
Effect of Different Vitamin D Vitamers on Vitamin D Status (VitD)
Effect of Different Vitamin D Vitamers on Vitamin D Status and Biomarkers for Bone Health and Cardiovascular Risk in Healthy Humans
Background: Dietary intake of vitamin D includes vitamin D3 (VitD3), 25-hydroxyvitamin D3 (25OHD3) and vitamin D2 (VitD2). However, the bioactivity of the different species is currently not scientifically established.
Objective: The aim of this study was to test the hypothesis that VitD3, 25OHD3 and VitD2 affected vitamin D status equally in humans and if rejected, to estimate the difference in activity.
Design: This study was designed as a 3 x 6 weeks (with 4 weeks run-in) double-blinded randomized cross-over study with 12 young, apparently healthy male volunteers and was performed during wintertime at 55 degree N. during the 4 weeks run-in period all volunteers received 10 ug/d VitD3 in order to achieve steady-state in vitamin D status. During the 3x6 weeks intervention periods the subjects received 10 ug/d VitD3, 10 ug/d 25OHD3 or 10 ug/d VitD2 in random order. Content of vitD3, VitD2, 25OHD3 and 25-hydroxyvitamin D2 (25OHD2) in serum were quantified my LC-MS/MS using 0.1 mL serum.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A total of 12 apparently healthy, free living male adults aged 20-30 years were recruited in this 3x6 weeks vitamin D intervention trial. Subjects were recruited among students from the University of Copenhagen through the use of advertisements placed around the University of Copenhagen. Volunteers were excluded if they had BMI > 27 kg/m2, had donated blood within the last three month, has any chronic diseases, used medication regularly, hypercalcemic, had excessive alcohol use, known malabsorption syndromes or used medication known to interfere with vitamin D metabolism. Furthermore, to decrease sun exposure, volunteers who planned to go skiing or travel south during the study was excluded. All subjects were Caucasian, had low habitual fish intake (less than twice a week) and were non-smokers. All subjects were instructed to maintain the same level of physical activity throughout the study and agreed to refrain from donating blood, as well as taking any kind of vitamin, mineral or dietary supplement other than supplements provided in the study. All subjects also agreed to abstain from taking solarium during the intervention. The study was approved by The Local Research Ethics Committee of Copenhagen and Frederiksberg. All participants gave written consent in accordance with the Helsinki declaration.
Design and conduct of study The present study was designed as a double blinded randomised cross over trial in which adult males were assigned to receive tablets containing 10 µg vitD3, 10 µg 25OHD3 and 10 µg vitD2 in random order. Prior to the intervention all subjects received 10 µg vitD3 for 4 weeks in order to achieve steady state in vitamin D status.
The vitamin D tablets (Jette) Compliance was assessed by tablet counting. The study was carried out in Copenhagen, Denmark (latitude 55 degree N). All subjects were recruited in September and run-in periods started in mid-October and the study was finished at the end of March. During the study the subjects were examined at screening, on day 1, 22 and day 42. Blood sample was collected 5 times; before run-in, at baseline, and at end of period, 1, 2 and 3, respectively. Blood samples were drawn after 12 h fasting, in the morning (between 0800 and 0900) by by a trained medical laboratory technician. Subjects were informed not to drink any kind of alcohol and to abstain from hard physical work 24 h before each blood sampling. They were, however, allowed to drink up to ½ L of water. Blood was collected by venipuncture into 10 ml dry tubes for analysis of serum vitamin D, in 5 ml tubes for analysis of serum PTH and in 7 ml Trace element free tubes for analysis of calcium. Blood samples was kept at 20 degree C and centrifuged after 40 min at 3000 g for 15 min. serum was then transferred into plastic tubes and stored at -80 degree C for vitamin d analysis or -20 degree C for Ca and PTH. Anthropometric measures, including height and weight, were taken at baseline. Body weight was measured to nearest 0.1 kg by use of an electronic decimal weight. Subjects were asked to empty their bladder before measuring weight only wearing underwear. The height was measured to nearest cm with the subject standing without shoes, gathering feeds and the head looking forward in horizontal plan.
Habitual intake of calcium and vitamin D was estimated by using a validated food-frequency questionnaire. A health and lifestyle questionnaire, which assessed habitual fish intake, physical activity, general health, smoking status and alcohol consumption, was completed at screening.
Laboratory analysis Serum 25OHD Serum intact parathyroid hormone Serum total calcium
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Frederiksberg, Denmark, 1958
- Department of Nutrition, Exercise and Sports
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- No drug use
- BMI< 25 kg/m2
- Do not eat fish more than 2 x weekly
- Not donated blood within 3 months
- No Holiday plans in Winter 2006-2007
Exclusion Criteria:
- Any disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Vitamin D3
10 ug/d of vitamin D3 for 6 weeks
|
10 ug/d of vitamin D3 for 6 weeks
|
Active Comparator: Vitamin D2
10 ug/d of vitamin D2 for 6 weeks
|
10 ug/d of vitamin D3 for 6 weeks
|
Active Comparator: 25OHD
10 ug/ of 25OHD for 6 weeks
|
10 ug/d of vitamin D3 for 6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum 25OHD
Time Frame: 1 year
|
Vitamin D status after intervention with different types of vitamin D
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Parathyreoideahormon
Time Frame: 1 year
|
Marker for ca status
|
1 year
|
Serum Ca
Time Frame: 1 year
|
Marker for Ca status
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susanne Bügel, Department of Nutrition, Exercise and Sports
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KF 01 322182
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vitamin D Status
-
University of UlsterNorthern Ireland Executive; HSC Public Health AgencyCompletedVitamin D Status | Vitamin D ConcentrationUnited Kingdom
-
Sheffield Children's NHS Foundation TrustCompleted
-
Bispebjerg HospitalThe Danish Medical Research CouncilCompleted
-
Bispebjerg HospitalVejle HospitalCompletedVitamin D StatusDenmark
-
Creighton UniversityThe UV FoundationCompleted
-
Creighton UniversityCompletedVitamin D StatusUnited States
-
University of TorontoCompleted
-
Tirang R. Neyestani, Ph.D.National Nutrition and Food Technology InstituteCompletedMaternal Vitamin D StatusIran, Islamic Republic of
-
University of UlsterDairy Council for Northern Ireland; Agri-food & Biosciences Institute; Center...Completed
-
National Nutrition and Food Technology InstituteCompletedHealthy | Vitamin D Status
Clinical Trials on Vitamin D3
-
Aga Khan UniversityCompletedVitamin D DeficiencyPakistan
-
Medical University of South CarolinaThrasher Research FundCompletedVitamin D Deficiency | PregnancyUnited States
-
Brigham and Women's HospitalNational Center for Maternal and Child Health Research, Mongolia; Zuun Kharaa...CompletedVitamin D Deficiency | PregnancyMongolia
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); Eunice Kennedy Shriver National Institute... and other collaboratorsCompletedHIV InfectionUnited States, Puerto Rico
-
Rutgers UniversityCompleted
-
Aalborg UniversityAalborg University Hospital; CCBR Aalborg A/S, Aalborg, DenmarkCompletedMigraine According to International Headache Society (IHS) Criteria (ICHD-II)Denmark
-
Nationwide Children's HospitalOhio State UniversityUnknownVitamin D Deficiency | AsthmaUnited States
-
Medical University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
Sanjay Gandhi Postgraduate Institute of Medical...CompletedPancreatitis, ChronicIndia
-
Brigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruiting