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Bariatric surgery patients tend to have malabsorption of many micronutrients such as B12, Iron and vitamin D postoperative. So in this study, a monthly high dose of vitamin D3 is giving to patients with their routine supplements and followed up for 6 months.
Hypothesis:Bariatric surgery subjects taking monthly high dose cholecalciferol supplements in addition to the standard vitamin D protocol will have a significant rise in serum vitamin D levels compared to the subjects taking only the usual vitamin D protocol.
Sun exposure and supplement use questionnaire:
A registered dietitian asked each subject for information on sun exposure, vitamins, medications, and any other supplement usage before each blood sample was taken.
Lab analysis included serum hydroxy vitamin D levels pre and 3 months postoperative.
Descriptive statistics which include both the means and standard deviations were calculated on the study variables. A paired sample t-test was used to determine if there was a significant difference in mean values pre and post vitamin D supplementation. An independent sample t-test was used to assess for significant differences in group (control vs. vitamin D supplement) means. A p-value < 0.05 was considered statistically significant. Statistical analyses were done using SPSS Version 21 (SPSS, Chicago, III, USA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D3 | Experimental | subjects taking the standard vitamin D protocol with added monthly high dose cholecalciferol of 100,000 IU cholecalciferol |
|
| Control | Active Comparator | group of subjects taking the standard vitamin D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D3 (Replesta) | Dietary Supplement | vitamin D group receive 2 replesta tablets (100,000 IU/month) of cholecalciferol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Impact of monthly high dose oral cholecalciferol on serum 25 hydroxy vitamin D levels in bariatric surgery subjects | To determine if there is a significant difference in mean serum vitamin D levels in the group of subjects taking the standard vitamin D protocol compared to subjects taking the standard vitamin D protocol with added monthly high dose cholecalciferol after bariatric surgery. This outcome measure is done by analysis of serum 25-OH vitamin D levels. | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Syn, MD | Texas Tech University Health Sciences Center | Principal Investigator |
| Mallory Boylan, PhD | Texas Tech University | Study Director |
| Hadil Subih, PhD | Texas Tech University | Study Chair |
| Shannon Owens, PhD | Texas Tech University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Tech University | Lubbock | Texas | 79405 | United States |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D014808 | Vitamin D Deficiency |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| vitamin D | Dietary Supplement |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |