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

Texas Tech University

Status and phase: Completed; Phase 1

Conditions: Vitamin D Deficiency; Morbid Obesity

Treatments: Dietary Supplement: vitamin D; Dietary Supplement: vitamin D3 (Replesta)

Study type: Interventional

Funder types: Other

Identifiers

NCT02477956

Highly dose of vitamin D3

Details and patient eligibility

About

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.

Full 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).

Enrollment: 31 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• morbidly obese and eligible for bariatric surgery

Exclusion criteria

• under 18 and over 60 years of age
• elevated serum vitamin D and calcium
• pregnant and lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 2 patient groups

vitamin D3

Experimental group

Description:

subjects taking the standard vitamin D protocol with added monthly high dose cholecalciferol of 100,000 IU cholecalciferol

Treatment:

Dietary Supplement: vitamin D3 (Replesta)

Control

Active Comparator group

Description:

group of subjects taking the standard vitamin D

Treatment:

Dietary Supplement: vitamin D