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

NCT02477956 | Completed Phase 1 DMC

• 1 other identifier: Highly dose of vitamin D3
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Vitamin D Deficiency

Keywords

vitamin D; obesity; bariatric surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

vitamin D3

EXPERIMENTAL

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

Dietary Supplement: vitamin D3 (Replesta)

Control

ACTIVE COMPARATOR

group of subjects taking the standard vitamin D

Dietary Supplement: vitamin D

Interventions

vitamin D3 (Replesta) DIETARY_SUPPLEMENT

vitamin D group receive 2 replesta tablets (100,000 IU/month) of cholecalciferol.

Also known as: Replesta

vitamin D3

vitamin D DIETARY_SUPPLEMENT

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• morbidly obese and eligible for bariatric surgery

You may not qualify if:

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

Sponsors & Collaborators

• Texas Tech University: lead

Study Sites (1)

Texas Tech University

Lubbock, Texas, 79405, United States

Location

MeSH Terms

Conditions

Obesity, Morbid; Vitamin D Deficiency; Obesity

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: June 23, 2015
• Study Start: November 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

US (1)