Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-26 @ 2:16 AM
Study NCT ID:
NCT02477956
Status:
COMPLETED
Last Update Posted:
2015-06-23
First Post:
2014-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Monthly High Dose of Vitamin D3 on Bariatric Surgery Patients
Sponsor:
Texas Tech University
Organization:
Study Overview
Official Title:
Impact of Monthly High Dose Oral Cholecalciferol on Serum 25 Hydroxy Vitamin D Levels in Bariatric Surgery Subjects
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: