Effects Vitamin D Suppletion on Postprandial Leukocyte Activation
DOSFEM
Effects of High and Low Dose Vitamin D Suppletion on Postprandial Leukocyte Activation, Oxidative Stress and Vascular Function in Healthy Overweight and Obese Females
1 other identifier
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 17, 2013
CompletedFirst Posted
Study publicly available on registry
October 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedOctober 5, 2017
October 1, 2017
2.2 years
October 17, 2013
October 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
2, 4, 6 and 8 hours postprandial
Secondary Outcomes (2)
Effect of vitamin D on oxidative stress
2,4,6 and 8 hours postprandial
Effect of vitamin D on vascular function
0,2,6,8 and 8 hours postprandial
Study Arms (2)
High dose vitamin D
ACTIVE COMPARATORVolunteers 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 COMPARATORVolunteers 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
Interventions
Single dose D-cura cholecalciferol drink 100 000 IU/ml, in total 300 000 IU (=3ml)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- The use of any kind of medication except oral contraceptives;
- Smoking;
- Pregnancy;
- The use of (multi)vitamin supplements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sint Franciscus Gasthuis
Rotterdam, South Holland, 3045 PM, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Manuel Castro Cabezas, MD, PhD
Sint Franciscus Gasthuis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 17, 2013
First Posted
October 23, 2013
Study Start
October 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
October 5, 2017
Record last verified: 2017-10