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Effect of Different Vitamin D Vitamers on Vitamin D Status (VitD)

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ClinicalTrials.gov Identifier: NCT02860663
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Vitamin D Status Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D2 Dietary Supplement: 25OHD Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Different Vitamin D Vitamers on Vitamin D Status and Biomarkers for Bone Health and Cardiovascular Risk in Healthy Humans
Study Start Date : August 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: Vitamin D3
10 ug/d of vitamin D3 for 6 weeks
Dietary Supplement: Vitamin D3
10 ug/d of vitamin D3 for 6 weeks

Active Comparator: Vitamin D2
10 ug/d of vitamin D2 for 6 weeks
Dietary Supplement: Vitamin D2
10 ug/d of vitamin D3 for 6 weeks

Active Comparator: 25OHD
10 ug/ of 25OHD for 6 weeks
Dietary Supplement: 25OHD
10 ug/d of vitamin D3 for 6 weeks




Primary Outcome Measures :
  1. Serum 25OHD [ Time Frame: 1 year ]
    Vitamin D status after intervention with different types of vitamin D


Secondary Outcome Measures :
  1. Serum Parathyreoideahormon [ Time Frame: 1 year ]
    Marker for ca status

  2. Serum Ca [ Time Frame: 1 year ]
    Marker for Ca status



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860663


Locations
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Denmark
Department of Nutrition, Exercise and Sports
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
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Principal Investigator: Susanne Bügel Department of Nutrition, Exercise and Sports
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Responsible Party: Arne Astrup, professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02860663    
Other Study ID Numbers: KF 01 322182
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents