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Completed

NCT Number: NCT01711905

Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers

The aim of this study is to investigate whether a supplementation of 20 µg Vitamin D3 per day for 12 weeks can be used to normalize vitamin d-Status

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Key information

Conditions

Deficiency of Vitamin D3

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naturwissenschaftliche Fakultät III

Halle, Saxony-Anhalt, 06120, Germany

About this study

It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to normalize insufficient vitamin d status and reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy volunteers
  • age between 18 and 70 years
  • informed consent

Exclusion criteria

  • use of antihypertensive medication
  • use of vitamin d or calcium supplements
  • known renal, inflammatory or malignant diseases
  • hypercalcemia or hypercalciuria
  • participation in other clinical studies
  • use of tanning booths during the study
  • pregnancy or lactating period

Treatment and study plan

Vitamin D3

Dietary Supplement

daily dosage of 20 µg Vitamin D3 for 12 weeks

Other names: cholecalciferol

Primary outcomes

  1. 25-hydroxyvitamin D3

    Time frame: after 12 weeks of supplementation

    major outcome variable is the increase of 25-hydroxyvitamin D3 in the treatment group in comparison with the placebo group

Secondary outcomes

  1. atherosclerotic risk factors

    Time frame: after 12 weeks of supplementation

    It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 can reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.

  2. inflammation

    Time frame: after 12 weeks of supplementation

    It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce inflammation as an atherosclerotic risk factor

  3. hyperlipidemia

    Time frame: after 12 weeks of supplementation

    It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce hyperlipidemia as an atherosclerotic risk factor

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers - a Randomized Trail

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 22, 2012
Registry last updated
Apr 22, 2013

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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