Obesity, Overweight
Conditions
Keywords
body weight, body compostion, vitamin D, blood pressure
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
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTvitamin D
6 drops of a vitamin D containing oil
Sponsors
Heart and Diabetes Center North-Rhine Westfalia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Body Weight From Baseline to 12 Months | baseline, 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change in LDL-cholsterol From Baseline to 12 Months | baseline, 12 months |
| Change in C-reactive Protein From Baseline to 12 Months | baseline, 12 months |
| Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months | baseline, 12 months |
| Change in Proinsulin From Baseline to 12 Months | baseline, 12 months |
| Change in Hb A1c From Baseline to 12 Months | change from baseline to 12 months |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experiment A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year. | 100 |
| Placebo Comparator A daily placebo oil is given for year | 100 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 18 | 17 |
Baseline characteristics
| Characteristic | Experiment | Placebo Comparator | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 98 Participants | 98 Participants | 196 Participants |
| Age, Continuous | 47.4 years STANDARD_DEVIATION 10.3 | 48.8 years STANDARD_DEVIATION 10.1 | 48.1 years STANDARD_DEVIATION 10.2 |
| Region of Enrollment Germany | 100 participants | 100 participants | 200 participants |
| Sex: Female, Male Female | 62 Participants | 72 Participants | 134 Participants |
| Sex: Female, Male Male | 38 Participants | 28 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
Change in Body Weight From Baseline to 12 Months
Time frame: baseline, 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experiment | Change in Body Weight From Baseline to 12 Months | -5.7 kg | Standard Deviation 5.8 |
| Placebo Comparator | Change in Body Weight From Baseline to 12 Months | -6.4 kg | Standard Deviation 5.6 |
Secondary
Change in 25-hydroxyvitamin D From Baseline to 12 Months
Time frame: baseline, 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experiment | Change in 25-hydroxyvitamin D From Baseline to 12 Months | 55.5 nmol/l | Standard Deviation 55.8 |
| Placebo Comparator | Change in 25-hydroxyvitamin D From Baseline to 12 Months | 11.8 nmol/l | Standard Deviation 36.3 |
Secondary
Change in Calcitriol From Baseline to 12 Months
Time frame: baseline, 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experiment | Change in Calcitriol From Baseline to 12 Months | 40.0 pmol/l | Standard Deviation 95 |
| Placebo Comparator | Change in Calcitriol From Baseline to 12 Months | 9.3 pmol/l | Standard Deviation 57 |
Secondary
Change in C-reactive Protein From Baseline to 12 Months
Time frame: baseline, 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experiment | Change in C-reactive Protein From Baseline to 12 Months | -0.03 mg/l | Standard Deviation 0.46 |
| Placebo Comparator | Change in C-reactive Protein From Baseline to 12 Months | -0.05 mg/l | Standard Deviation 0.68 |
Secondary
Change in Fat Mass From Baseline to 12 Months
Time frame: baseline, 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experiment | Change in Fat Mass From Baseline to 12 Months | -4.1 kg | Standard Deviation 4.6 |
| Placebo Comparator | Change in Fat Mass From Baseline to 12 Months | -4.9 kg | Standard Deviation 4.9 |
Secondary
Change in Hb A1c From Baseline to 12 Months
Time frame: change from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experiment | Change in Hb A1c From Baseline to 12 Months | -0.25 % glycosylated hemoglobin | Standard Deviation 0.23 |
| Placebo Comparator | Change in Hb A1c From Baseline to 12 Months | -0.25 % glycosylated hemoglobin | Standard Deviation 0.23 |
Secondary
Change in LDL-cholsterol From Baseline to 12 Months
Time frame: baseline, 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experiment | Change in LDL-cholsterol From Baseline to 12 Months | 0.19 mmol/l | Standard Deviation 1.03 |
| Placebo Comparator | Change in LDL-cholsterol From Baseline to 12 Months | -0.09 mmol/l | Standard Deviation 0.17 |
Secondary
Change in Parathyroid Hormone From Baseline to 12 Months
Time frame: baseline, 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experiment | Change in Parathyroid Hormone From Baseline to 12 Months | -1.24 pmol/l | Standard Deviation 2.18 |
| Placebo Comparator | Change in Parathyroid Hormone From Baseline to 12 Months | -0.91 pmol/l | Standard Deviation 2.55 |
Secondary
Change in Proinsulin From Baseline to 12 Months
Time frame: baseline, 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experiment | Change in Proinsulin From Baseline to 12 Months | -4.6 pmol/l | Standard Deviation 14.9 |
| Placebo Comparator | Change in Proinsulin From Baseline to 12 Months | -4.1 pmol/l | Standard Deviation 9.9 |
Secondary
Change in Triglycerides From Baseline to 12 Months
Time frame: baseline, 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experiment | Change in Triglycerides From Baseline to 12 Months | -0.19 mmol/l | Standard Deviation 0.54 |
| Placebo Comparator | Change in Triglycerides From Baseline to 12 Months | 0.03 mmol/l | Standard Deviation 0.5 |
Secondary
Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months
Time frame: baseline, 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experiment | Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months | -0.80 pg/ml | Standard Deviation 2.5 |
| Placebo Comparator | Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months | -0.26 pg/ml | Standard Deviation 2.9 |