Effects Vitamin D Suppletion on Postprandial Leukocyte Activation

Atherosclerosis Clinical Trial

— DOSFEM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967459
• Other study ID #: NL44804.101.13
• Status: Completed
• Phase: N/A
• First received: October 17, 2013
• Last updated: October 4, 2017
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: October 2017
• Source: Sint Franciscus Gasthuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Atherosclerosis
• Leukocyte Activation Disorder
• Oxidative Stress

Intervention

Drug:
• Cholecalciferol
Single dose D-cura cholecalciferol drink 100 000 IU/ml, in total 300 000 IU (=3ml)
• Cholecalciferol
Single dose D-cura cholecalciferol drink 250 000 IU/ml, in total 75 000 IU (=3ml)

Locations

Country	Name	City	State
Netherlands	Sint Franciscus Gasthuis	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Sint Franciscus Gasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	2,4,6 and 8 hours postprandial
Secondary	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)	0,2,6,8 and 8 hours postprandial