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

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ClinicalTrials.gov Identifier: NCT02477956
Recruitment Status : Completed
First Posted : June 23, 2015
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
Texas Tech University

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.


Condition or disease Intervention/treatment Phase
Morbid Obesity Vitamin D Deficiency Dietary Supplement: vitamin D3 (Replesta) Dietary Supplement: vitamin D Phase 1

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Impact of Monthly High Dose Oral Cholecalciferol on Serum 25 Hydroxy Vitamin D Levels in Bariatric Surgery Subjects
Study Start Date : November 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: vitamin D3
subjects taking the standard vitamin D protocol with added monthly high dose cholecalciferol of 100,000 IU cholecalciferol
Dietary Supplement: vitamin D3 (Replesta)
vitamin D group receive 2 replesta tablets (100,000 IU/month) of cholecalciferol.
Other Name: Replesta

Active Comparator: Control
group of subjects taking the standard vitamin D
Dietary Supplement: vitamin D



Primary Outcome Measures :
  1. Impact of monthly high dose oral cholecalciferol on serum 25 hydroxy vitamin D levels in bariatric surgery subjects [ Time Frame: one year ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477956


Locations
United States, Texas
Texas Tech University
Lubbock, Texas, United States, 79405
Sponsors and Collaborators
Texas Tech University
Investigators
Principal Investigator: David Syn, MD Texas Tech University Health Sciences Center
Study Director: Mallory Boylan, PhD Texas Tech University
Study Chair: Hadil Subih, PhD Texas Tech University
Study Chair: Shannon Owens, PhD Texas Tech University

Responsible Party: Texas Tech University
ClinicalTrials.gov Identifier: NCT02477956     History of Changes
Other Study ID Numbers: Highly dose of vitamin D3
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

Keywords provided by Texas Tech University:
vitamin D
obesity
bariatric surgery

Additional relevant MeSH terms:
Vitamin D Deficiency
Obesity, Morbid
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Obesity
Overnutrition
Overweight
Body Weight
Signs and Symptoms
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents