Vitamin and Mineral Supplementation Post Bariatric Surgery (RCTVMSSG)

June 26, 2016 updated by: Juma Alkaabi, United Arab Emirates University

A Randomized Controlled Trial of Vitamin and Mineral Supplementation Post Bariatric Surgery: Sleeve Gastrectomy

Bariatric surgery is emerging as an essential treatment option for the management of obesity and its associated comorbidities. Many patients present for surgery have pre-existing low blood vitamin levels, thus all bariatric surgical procedures compromise nutrition to varying extents, and may present potential threat of micronutrient deficiencies. Therefore, long term nutritional monitoring and follow-ups are vital components of all bariatric surgical patients. However, there are no current standard practices in United Arab Emirates (UAE) for the biochemical monitoring and replacement of essential micronutrients in patients undergoing bariatric surgery particularly the most performed Sleeve Gastrectomy. Medical practice guidelines recommend nutritional care however, the dose and route of administration supplementation after surgery based on randomized controlled trials is not yet established. Till tow no scientific study has been performed on monitoring vitamins and minerals levels following bariatric surgery among UAE population. Therefore, present study is aimed to determine the dose and route of administration of vitamins and minerals in improving the micronutrient deficiencies post-operatively. Two standard different dosage forms (oral /parenteral) of vitamins and minerals will be given to the patients who had undergone sleeve gastrectomy at Tawam Hospital. The dosages of the supplementations are within the international recommendations and patients will be followed up closely for a period of one year. The effect of nutritional deficiencies on micronutrient level and quality of life (QOL) will be assessed. This will help the medical practitioners to prove the optimal possible nutrition for patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in Tawam Hospital where patients come for their routine bariatric surgery. A written informed consent will be taken from all the patients willing to participate in the study. Patients would be informed about the objectives / goals of the study.

Study Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Arab Emirates
      • Al Ain, United Arab Emirates
        • Faculty of Medicine and Health Sciences
    • AB
      • Al Ain, AB, United Arab Emirates
        • Faculty of Medicine and Health Sciences UAE University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 18-60 years;
  • No medical or psychiatric contraindications;
  • BMI>35 kg/m2 with co-morbidities or BMI > 40 kg/m2 prior to the bariatric surgery.

Exclusion Criteria:

  • • Documented severe micronutrient deficiency that require treatment

    • Documented poor compliance;
    • History of in concordance to medication;
    • Inflammatory bowel disease, malignant or debilitating medical conditions;
    • Known hemoglobinopathies or those diagnosed with pernicious anaemia;
    • Known history of kidney renal stones or history of hypercalcaemia;
    • Significant longstanding medical complications that affect micronutrient status;
    • Severe psychiatric illness;
    • Women who are lactating, pregnant or planning pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A, 'vitamins and minerals'

"Ergocalciferol , Vitamin B12, Calcium /D ", "Iron" or "Centrium".

Ergocalciferol 300,000 IM - Every 3 months Oral Vitamin B12 tablets daily (500mcg) Calcium /D Tab 600-200mg Centrium -1 Tablet Daily

Mineral:

Iron preparation - Daily (47mg)
Dietary supplement: Vitamins and Minerals
Multivitamins and Minerals supplementation
Active Comparator: Group B, 'vitamins and minerals'

"Ergocalciferol , Vitamin B12, Calcium /D ", "Iron" or "Centrium".

Centrium - 1 Tablet daily Ergocalciferol 50000 IU once every two weeks Vitamin B12 1000mcg IM every three months Calcium /D Tab 600-200mg

Minerals:

Iron preparation - Daily (47mg)
Dietary supplement: Vitamins and Minerals
Multivitamins and Minerals supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
monitor the levels of micronutrients of Iron
Time Frame: 1 year
Change in micronutrients level of Iron
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
monitor the levels of uric acid
Time Frame: 1year
Change in level of uric acid
1year
complications resulting from IM injections
Time Frame: 1 year
Number of complications resulting from IM injections
1 year
monitor the levels of calcium
Time Frame: 1 year
Change in level of calcium
1 year
monitor the levels of Vitamin A
Time Frame: 1 year
Change in level of Vitamin A
1 year
monitor the levels of Vitamin D
Time Frame: 1 year
Change in level of Vitamin D
1 year
monitor the levels of Serum folate
Time Frame: 1 year
Change in level of Serum folate
1 year
monitor the levels of Vitamin B12
Time Frame: 1 year
Change in level of Vitamin B12
1 year
monitor the levels of Serum methyl malonate
Time Frame: 1 year
Change in level of Serum methyl malonate
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United Arab Emirates University

Investigators

  • Study Chair: Salah Gariballa, MD, United Arab Emirates University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

June 19, 2016

First Submitted That Met QC Criteria

June 26, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 26, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD IRR 430#

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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