Insulin Resistance, Obesity
Conditions
Keywords
Vitamin D,, Oral supplementation,, Obese males
Brief summary
Hypothesis: Oral Supplementation of Vitamin D can Reduce Hypersecretion of Parathyroid Hormone and Insulin Resistance in Obese Chinese Males. Protocol: Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) or eight weeks to the obese males compared with the normal-weight males. Index measures were conducted at baseline and endpoint.
Interventions
DIETARY_SUPPLEMENTOral supplementation of vitamin D
Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) for eight weeks to the obese males compared with the normal-weight males. The chemical form of vitamin D is cholecalciferol capsuled as fine powder.
Sponsors
Danone Institute China Diet Nutrition Research and Communication
Shenzhen Center for Chronic Disease Control
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
23 Years to 66 Years
Healthy volunteers
Yes
Inclusion criteria
* body mass index (BMI) ≥ 28kg/m2 or 18.5 ≤ BMI \< 24 (kg/m2) * non vegetarian Han Chinese and did not smoke, drink, nor take vitamin D supplements for \> 2 y * fasting serum glucose \< 7.0 mmol/L * serum glucose of 2 hr after 75 g oral glucose loading \< 11.1 mmol/L * normal functioning of liver and kidney evaluated by alkaline phosphatase, aspartate aminotransferase, creatinine, and uric acid
Exclusion criteria
* not match the above inclusion criteria * diagnosed as having any organic diseases were excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L) | Endpoint and baseline of the 8 weeks' trial |
Countries
China
Participant flow
Recruitment details
Subjects were recruited at a medical clinic (Health Service Center of Shuiku Community, Shenzhen, China) in May, 2011.
Pre-assignment details
After enrollment, baseline information of the volunteers including vitamin D nutritional status, health records, etc. were evaluated. Including and excluding criteria were used to select the subjects who were suitable for the intervention trial.
Participants by arm
| Arm | Count |
|---|---|
| Normal-weight Group | 21 |
| Obese Group | 21 |
| Total | 42 |
Baseline characteristics
| Characteristic | Obese Group | Normal-weight Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 21 Participants | 41 Participants |
| Age Continuous | 44.7 years STANDARD_DEVIATION 8.8 | 34.4 years STANDARD_DEVIATION 8 | 39.5 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment China | 21 participants | 21 participants | 42 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 21 Participants | 21 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 22 |
| serious Total, serious adverse events | 0 / 21 | 0 / 22 |
Outcome results
Primary
Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L)
Time frame: Endpoint and baseline of the 8 weeks' trial
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Obese Group | Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L) | Endpoint plasma 25(OH)D level | 116.7 nmol/L | Standard Deviation 20.3 |
| Obese Group | Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L) | Baseline plasma 25(OH)D level | 46.1 nmol/L | Standard Deviation 9.1 |
| Normal-weight Group | Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L) | Endpoint plasma 25(OH)D level | 181.3 nmol/L | Standard Deviation 30.2 |
| Normal-weight Group | Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L) | Baseline plasma 25(OH)D level | 52.8 nmol/L | Standard Deviation 17.8 |