N/A
Completed N=200
Vitamin D Effects in Overweight Patients
Source: ClinicalTrials.gov NCT00493012 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Change in Body Weight From Baseline to 12 Months — -5.7; -6.4 kg
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
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 | — |
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
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. Informational only — not medical advice.