NCT02477956

Effect of a Monthly High Dose of Vitamin D3 on Bariatric Surgery Patients

Impact of Monthly High Dose Oral Cholecalciferol on Serum 25 Hydroxy Vitamin D Levels in Bariatric Surgery Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Texas Tech University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Morbid Obesity
• Vitamin D Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	vitamin D3 (Replesta)	vitamin D group receive 2 replesta tablets (100,000 IU/month) of cholecalciferol.
DIETARY_SUPPLEMENT	vitamin D

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2015-06-23
• Last updated: 2015-06-23

Locations

1 site across 1 country: United States