N/A N=200 Randomized Double-blind Prevention

Vitamin D Effects in Overweight Patients

Overweight · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT00493012 ↗

Enrolled (actual)

200

Serious AEs

0.0%

Results posted

Mar 2012

Primary outcome: Primary: Change in Body Weight From Baseline to 12 Months — -5.7; -6.4 kg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: vitamin D (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Heart and Diabetes Center North-Rhine Westfalia
Primary completion: Dec 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Body Weight From Baseline to 12 Months	-5.7; -6.4	—
SECONDARY Change in Fat Mass From Baseline to 12 Months	-4.1; -4.9	—
SECONDARY Change in 25-hydroxyvitamin D From Baseline to 12 Months	55.5; 11.8	—
SECONDARY Change in Calcitriol From Baseline to 12 Months	40.0; 9.3	—
SECONDARY Change in Parathyroid Hormone From Baseline to 12 Months	-1.24; -0.91	—
SECONDARY Change in Triglycerides From Baseline to 12 Months	-0.19; 0.03	—
SECONDARY Change in LDL-cholsterol From Baseline to 12 Months	0.19; -0.09	—
SECONDARY Change in C-reactive Protein From Baseline to 12 Months	-0.03; -0.05	—
SECONDARY Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months	-0.80; -0.26	—
SECONDARY Change in Proinsulin From Baseline to 12 Months	-4.6; -4.1	—
SECONDARY Change in Hb A1c From Baseline to 12 Months	-0.25; -0.25	—

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00493012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.