Clinical trial NCT02817256: Vitamin and Mineral Supplementation Post Bariatric Surgery
Official title: A Randomized Controlled Trial of Vitamin and Mineral Supplementation Post Bariatric Surgery: Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complications of Other Bariatric Procedure
Lead sponsor: United Arab Emirates University
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: monitor the levels of micronutrients of Iron
timeFrame: 1 year
Secondary outcomes:
measure: monitor the levels of uric acid
timeFrame: 1year
measure: complications resulting from IM injections
timeFrame: 1 year
measure: monitor the levels of calcium
timeFrame: 1 year
measure: monitor the levels of Vitamin A
timeFrame: 1 year
measure: monitor the levels of Vitamin D
timeFrame: 1 year
measure: monitor the levels of Serum folate
timeFrame: 1 year
measure: monitor the levels of Vitamin B12
timeFrame: 1 year
measure: monitor the levels of Serum methyl malonate
timeFrame: 1 year
Other outcomes:
Locations:
city: Al Ain
country: United Arab Emirates
facility: Faculty of Medicine and Health Sciences UAE University
state: AB
city: Al Ain
country: United Arab Emirates
facility: Faculty of Medicine and Health Sciences
Study officials:
affiliation: United Arab Emirates University
name: Salah Gariballa, MD
role: STUDY_CHAIR
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