NCT00493012

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

March 8, 2012

Completed
Last Updated

April 13, 2017

Status Verified

May 1, 2011

Enrollment Period

1.9 years

First QC Date

June 26, 2007

Results QC Date

March 29, 2011

Last Update Submit

March 16, 2017

Conditions

OverweightObesity

Keywords

body weightbody compostionvitamin Dblood pressure

Outcome Measures

Primary Outcomes (1)

  • Change in Body Weight From Baseline to 12 Months

    baseline, 12 months

Secondary Outcomes (10)

  • Change in Fat Mass From Baseline to 12 Months

    baseline, 12 months

  • Change in 25-hydroxyvitamin D From Baseline to 12 Months

    baseline, 12 months

  • Change in Calcitriol From Baseline to 12 Months

    baseline, 12 months

  • Change in Parathyroid Hormone From Baseline to 12 Months

    baseline, 12 months

  • Change in Triglycerides From Baseline to 12 Months

    baseline, 12 months

  • +5 more secondary outcomes

Study Arms (2)

vitamin D oil

EXPERIMENTAL

oil containing vitamin D (Vigantol oil)

Dietary Supplement: vitamin D

placebo oil

PLACEBO COMPARATOR

oil not containg vitamin D (Migliol oil)

Dietary Supplement: vitamin D

Interventions

vitamin DDIETARY_SUPPLEMENT

6 drops of a vitamin D containing oil

placebo oilvitamin D oil

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index \> 27 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart and Diabetes Center NRW

Bad Oeynhausen, North-Rhine Westfalia, 32545, Germany

Location

Related Publications (1)

  • Zittermann A, Frisch S, Berthold HK, Gotting C, Kuhn J, Kleesiek K, Stehle P, Koertke H, Koerfer R. Vitamin D supplementation enhances the beneficial effects of weight loss on cardiovascular disease risk markers. Am J Clin Nutr. 2009 May;89(5):1321-7. doi: 10.3945/ajcn.2008.27004. Epub 2009 Mar 25.

    PMID: 19321573RESULT

Related Links

MeSH Terms

Conditions

OverweightObesityBody Weight

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Armin Zittermann
Organization
Heart and Diabetes Center North Rhine-Westfalia
azittermann@hdz-nrw.de
+49 5731 97

Study Officials

  • Heinrich Koertke, MD

    Institute of Applied Telemedicine, Heart and Diabetes Center North-Rhine Westfalia, 32545 Bad Oeynhausen, Germany

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 27, 2007

Study Start

January 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 13, 2017

Results First Posted

March 8, 2012

Record last verified: 2011-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)