Obesity, Overweight
Conditions
Keywords
Vitamin D, Metabolic profile, Overweight, Obesity
Brief summary
The investigators investigated the effect of vitamin D3 supplementation on metabolic profile (anthropometric measures, blood pressure Lipids, lipoproteins and glycemic indices) in overweight or obese women.
Detailed description
Vitamin D deficiency is a worldwide health problem and is determined as a risk factor in Cardiometabolic disorders including Cardiovascular disease, Metabolic syndrome, and type 2 diabetes mellitus. The investigators investigated the effect of vitamin D3 supplementation on metabolic profile in overweight or obese women. A double blind randomized clinical trial was conducted in 77 premenopause overweight or obese women. Participants were classified into two groups : vitamin D supplementation \[1000 IU/day as cholecalciferol tablets (n=39)\] or placebo (n=38). Vein blood samples were taken after at least 12 hours overnight fasting. Selected anthropometric measures, blood pressure Lipids, lipoproteins and glycemic indices were measured at baseline and after 12 weeks. Body fat mass was determined using BIA. Also the investigators assessed dietary intake using 24 hours food recall and semi-quantitative food frequency and physical activity using IPAQ questionnaires. The investigators conducted the study between October 2009 and March 2010 at the Medical school, Tehran, Iran. Recruitment began in October 2009 via advertisements and was terminated in October 2009. The investigators excluded patients with a history of Cardiovascular disease, Liver disease, Gastrointestinal disease, Kidney disease, diabetes mellitus, and Osteoporosis. Moreover, pregnancy, lactation, vegetarianism, and intake of dietary supplements were the exclusion criteria.
Interventions
DIETARY_SUPPLEMENTPlacebo
dosage form:lactose dosage: 25 micrograms frequency: every day duration: 12weeks
DIETARY_SUPPLEMENTvitamin D
dosage form:cholecalciferol dosage: 25 micrograms (1000 International Unit) frequency: every day duration: 12weeks
Sponsors
Shahid Beheshti University of Medical Sciences
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Female * 18-50 years old * Premenopause * BMI ≥25
Exclusion criteria
* Cardiovascular disease * Liver disease * Gastrointestinal disease * Kidney disease * Diabetes mellitus * Osteoporosis * Pregnancy * Lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Fat Mass | 3 months minus baseline | Body composition was assessed by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).The principle of measuring the flow of current through the body is dependent on the frequency applied. At low frequencies, the current cannot bridge the cellular membrane and will pass predominantly through the extra-cellular space. At higher frequencies penetration of the cell membrane occurs and the current is conducted by both the extra-cellular water (ECW) and intra-cellular water (ICW).FFM can be estimated because FFM is primarily composed of water. |
| Change in Glucose Concentrations | 3 months minus baseline | — |
| Change in Post Load Glucose Concentrations | 3 months minus baseline | It was performed 2 hours after 75g oral glucose tolerance test (75-OGTT). |
| Change in Insulin Concentrations | 3 months minus baseline | — |
Countries
Iran
Participant flow
Recruitment details
In November 2009 we distributed advertisements in campus of Tehran University of Medical Sciences (TUMS) and invited all female students and employee to participate in our study.
Participants by arm
| Arm | Count |
|---|---|
| Lactose In placebo group women used a pill of 25 microgram lactose every day for 12-weeks. | 38 |
| Vitamin D In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks. | 39 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Vitamin D | Lactose | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 38 Participants | 77 Participants |
| Age Continuous | 37 years STANDARD_DEVIATION 8 | 38.9 years STANDARD_DEVIATION 7 | 38 years STANDARD_DEVIATION 8 |
| Region of Enrollment Iran, Islamic Republic of | 39 participants | 38 participants | 77 participants |
| Sex: Female, Male Female | 39 Participants | 38 Participants | 77 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 38 | 0 / 39 |
| serious Total, serious adverse events | 0 / 38 | 0 / 39 |
Outcome results
Primary
Change in Body Fat Mass
Body composition was assessed by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).The principle of measuring the flow of current through the body is dependent on the frequency applied. At low frequencies, the current cannot bridge the cellular membrane and will pass predominantly through the extra-cellular space. At higher frequencies penetration of the cell membrane occurs and the current is conducted by both the extra-cellular water (ECW) and intra-cellular water (ICW).FFM can be estimated because FFM is primarily composed of water.
Time frame: 3 months minus baseline
Population: We assessed body composition by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D | Change in Body Fat Mass | -2.7 kg | Standard Deviation 2 |
| Placebo | Change in Body Fat Mass | -0.4 kg | Standard Deviation 2 |
p-value: 0.001ANCOVA
Primary
Change in Glucose Concentrations
Time frame: 3 months minus baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D | Change in Glucose Concentrations | -0.28 mmol/L | Standard Deviation 0.4 |
| Placebo | Change in Glucose Concentrations | -0.65 mmol/L | Standard Deviation 0.4 |
Primary
Change in Insulin Concentrations
Time frame: 3 months minus baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D | Change in Insulin Concentrations | -24.8 pmol/L | Standard Deviation 20.2 |
| Placebo | Change in Insulin Concentrations | -19 pmol/L | Standard Deviation 23.3 |
Primary
Change in Post Load Glucose Concentrations
It was performed 2 hours after 75g oral glucose tolerance test (75-OGTT).
Time frame: 3 months minus baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D | Change in Post Load Glucose Concentrations | -0.29 mmol/L | Standard Deviation 0.9 |
| Placebo | Change in Post Load Glucose Concentrations | -0.3 mmol/L | Standard Deviation 1.1 |