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OpenTrials
Completed

NCT Number: NCT00493012

Vitamin D Effects in Overweight Patients

The purpose of the study is to investigate in overweight patients who are on a telemedically guided weight loss program the influence of a daily vitamin D supplement on

* weight loss and body composition, * selected inflammation markers and biochemical parameters of lipid and glucose metabolism . * selected clinical parameters such as blood pressure, heart rate

Completed

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart and Diabetes Center NRW

Bad Oeynhausen, North-Rhine Westfalia, 32545, Germany

About this study

Obese patients are known to have low levels of vitamin D metabolites. There is some evidence that vitamin D and/or dietary calcium may influence energy metabolism and body weight. We therefore perform a prospective controlled trial with 200 overweight (Body mass index 27-29.9 kg/m2) and obese subjects (Body mass index >= 30 kg/m2) who are on a telemedically guided weight loss program. Subjects randomly receive a daily vitamin D supplement or a placebo for 1 year. Participants have to send their body weight data to the study office weekly. In addition, a nutritionist at the study office has to be contacted weekly to receive further support concerning the weight loss program. Dietary records have to be completed monthly. Clinical parameters and blood samples are collected at baseline, and after 6 and 12 months. It is the aim of the study to investigate the vitamin D effects on weight loss and body composition. In addition, possible vitamin D effects on clinical and selected biochemical parameters should be assessed. These parameters include heart rate, blood pressure, inflammation markers, and parameters of lipid and glucose metablolism.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index > 27 kg/m2

Exclusion criteria

  • pregnant and lactating women
  • vegetarians
  • patients with renal insufficiency (creatinine > 1.5 mg/dl)
  • History of renal stones and gallstones
  • patients with insulin dependent diabetes mellitus
  • parallel participation in another clinical study
  • missing informed consent
  • subjects with pacemaker implantation

Treatment and study plan

Vitamin D

Dietary Supplement

6 drops of a vitamin D containing oil

Primary outcomes

  1. Change in Body Weight From Baseline to 12 Months

    Time frame: baseline, 12 months

Secondary outcomes

  1. Change in Fat Mass From Baseline to 12 Months

    Time frame: baseline, 12 months

  2. Change in 25-hydroxyvitamin D From Baseline to 12 Months

    Time frame: baseline, 12 months

  3. Change in Calcitriol From Baseline to 12 Months

    Time frame: baseline, 12 months

  4. Change in Parathyroid Hormone From Baseline to 12 Months

    Time frame: baseline, 12 months

  5. Change in Triglycerides From Baseline to 12 Months

    Time frame: baseline, 12 months

  6. Change in LDL-cholsterol From Baseline to 12 Months

    Time frame: baseline, 12 months

  7. Change in C-reactive Protein From Baseline to 12 Months

    Time frame: baseline, 12 months

  8. Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months

    Time frame: baseline, 12 months

  9. Change in Proinsulin From Baseline to 12 Months

    Time frame: baseline, 12 months

  10. Change in Hb A1c From Baseline to 12 Months

    Time frame: change from baseline to 12 months

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Registry information

Official study title

Effects of a Vitamin D (Cholecalciferol) Supplement on Body Composition, Blood Pressure, and Lipid and Diabetes Parameters in Overweight Patients Attending a Telemedically Guided Weight Loss Program

Acronym: SMART

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 27, 2007
Registry last updated
Apr 13, 2017

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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