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NCT Number: NCT01248442

Immune and Metabolic Effects of Vitamin D Supplementation in Healthy Humans

In this placebo controlled study the investigators aim to investigate the effect of a 3 month vitamin D supplementation on parameters of the immune, endocrine and metabolic system in healthy women and men. Vitamin D. In a pilot study the investigators showed an increase of certain immune cells, which regulate immunotolerance, the investigators therefore try to confirm these results with a placebo group. Furthermore the investigators assess the effect of vitamin D on the glucose metabolism and hormone levels.

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Key information

Conditions

Healthy Humans Autoimmune Diseases Avitaminosis Deficiency Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University Graz

Graz, 8036, Austria

About this study

This is a randomized double-blind placebo controlled trial, with the aim to investigate the effect of a Vitamin D supplementation on parameters of the immune, endocrine and metabolic system in healthy humans without diabetes and obesity.

The primary aim is to assess the effect of vitamin D supplementation of the number and function of peripheral regulatory T-cells (Tregs). The investigators will measure the Tregs at baseline and monthly for 3 months. Furthermore the investigators assess additional immune cells from the adaptive immunosystem.

Furthermore the investigators will perform a standard mixed meal tolerance test at baseline and 3 months following the supplementation in order to assess the insulin secretion in vivo.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 10 years
  • healthy subjects without chronic disease

Exclusion criteria

  • Hypercalcemia >2,65 mmol/L
  • pregnancy and lactation period
  • acute infections
  • chronic disease requiring treatment

Treatment and study plan

Cholecalciferol

Drug

monthly dose of 140.000 IU of cholecalciferol orally, 3 times.

Other names: Oleovit D3

Placebo

Drug

Matching Placebo

Other names: Almondoil

Primary outcomes

  1. Increase and function of peripheral regulatory T-cells

    Time frame: 3 months

    The level and function of the regulatory T-cells will be compared between the two groups.

Secondary outcomes

  1. immunophenotyping

    Time frame: 3 months

    The effect of vitamin D on circulating immune cells and cytokine secretion will be measured at basal and after 3 months.

  2. Renin and aldosterone concentrations

    Time frame: 3 months

    serum renin and aldosterone levels will be measured basal and after 3 months.

  3. Insulin secretion

    Time frame: 3 months

    Insulin secretion assessed with a mixed meal tolerance test will be performed basal and after 3 months

  4. calcium levels

    Time frame: 3 months

    serum calcium levels will be measured basal and monthly for 3 months.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Placebo Controlled Study to Assess the Effects of Vitamin D Supplementation on Parameters of the Immune, Endocrine and Metabolic System in Healthy Women and Men.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 25, 2010
Registry last updated
Feb 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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