Complications of Other Bariatric ProcedureRCTVMSSGNCT02817256
Vitamin and Mineral Supplementation Post Bariatric Surgery
A study testing Vitamins and Minerals in people with Complications of Other Bariatric Procedure, run by United Arab Emirates University at 2 sites in United Arab Emirates.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Complications of Other Bariatric Procedure
- What is being tested?
- Vitamins and Minerals
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesUnited Arab Emirates
- Study dates
- Oct 2016to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- • 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;
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- Significant longstanding medical complications that affect micronutrient status;
- Severe psychiatric illness;
- Women who are lactating, pregnant or planning pregnancy.
Trial locations and contacts
2 sites in 1 country.
United Arab Emirates2 sites
Faculty of Medicine and Health Sciences UAE University
Al Ain City, AB
Faculty of Medicine and Health Sciences
Al Ain City
About this study
Official title: 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.
Read the 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.
- Being tested
- Vitamins and Minerals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamins and MineralsDietary supplement
Multivitamins and Minerals supplementation
| Study group | Role | What they receive |
|---|---|---|
| Group A, 'vitamins and minerals' | Active comparator | "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) Receives: Dietary Supplement: Vitamins and Minerals |
| Group B, 'vitamins and minerals' | Active comparator | "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) Receives: Dietary Supplement: Vitamins and Minerals |
What is being measured
The primary outcome is the main question the study is designed to answer.
monitor the levels of micronutrients of Iron
Change in micronutrients level of Iron
Measured: 1 year
Secondary outcomes (8)
monitor the levels of uric acid
Change in level of uric acid
Measured: 1year
complications resulting from IM injections
Number of complications resulting from IM injections
Measured: 1 year
monitor the levels of calcium
Change in level of calcium
Measured: 1 year
monitor the levels of Vitamin A
Change in level of Vitamin A
Measured: 1 year
monitor the levels of Vitamin D
Change in level of Vitamin D
Measured: 1 year
monitor the levels of Serum folate
Change in level of Serum folate
Measured: 1 year
monitor the levels of Vitamin B12
Change in level of Vitamin B12
Measured: 1 year
monitor the levels of Serum methyl malonate
Change in level of Serum methyl malonate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Complications of Other Bariatric ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Arab Emirates University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juma Alkaabi, United Arab Emirates University
- Investigators
- Salah Gariballa, MD, Study chair, United Arab Emirates University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817256
- Sponsor's protocol ID
- CRD IRR 430#
- Acronym
- RCTVMSSG
- Status last verified
- Jun 2016
- First submitted
- 19 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gariballa S, Afandi B, Abuhaltem M, Yassin J, Habib H, Ibrahim W. Oxidative damage and inflammation in obese diabetic Emirati subjects supplemented with antioxidants and B-vitamins: a randomized placebo-controlled trail. Nutr Metab (Lond). 2013 Feb 4;10(1):21. doi: 10.1186/1743-7075-10-21.
PubMed 23379892Rhines SD, Heins JR. Pharmacotherapy for obesity and weight loss. S D Med. 2013 Nov;66(11):471, 473. No abstract available.
PubMed 24383264Bennett JM, Mehta S, Rhodes M. Surgery for morbid obesity. Postgrad Med J. 2007 Jan;83(975):8-15. doi: 10.1136/pgmj.2006.048868.
PubMed 17267672Coupaye M, Riviere P, Breuil MC, Castel B, Bogard C, Dupre T, Flamant M, Msika S, Ledoux S. Comparison of nutritional status during the first year after sleeve gastrectomy and Roux-en-Y gastric bypass. Obes Surg. 2014 Feb;24(2):276-83. doi: 10.1007/s11695-013-1089-6.
PubMed 24122661Batsis JA, Lopez-Jimenez F, Collazo-Clavell ML, Clark MM, Somers VK, Sarr MG. Quality of life after bariatric surgery: a population-based cohort study. Am J Med. 2009 Nov;122(11):1055.e1-1055.e10. doi: 10.1016/j.amjmed.2009.05.024.
PubMed 19854336Raoof M, Naslund I, Rask E, Karlsson J, Sundbom M, Edholm D, Karlsson FA, Svensson F, Szabo E. Health-Related Quality-of-Life (HRQoL) on an Average of 12 Years After Gastric Bypass Surgery. Obes Surg. 2015 Jul;25(7):1119-27. doi: 10.1007/s11695-014-1513-6.
PubMed 25566743Myers JA, Clifford JC, Sarker S, Primeau M, Doninger GL, Shayani V. Quality of life after laparoscopic adjustable gastric banding using the Baros and Moorehead-Ardelt Quality of Life Questionnaire II. JSLS. 2006 Oct-Dec;10(4):414-20.
PubMed 17575749Moize V, Andreu A, Flores L, Torres F, Ibarzabal A, Delgado S, Lacy A, Rodriguez L, Vidal J. Long-term dietary intake and nutritional deficiencies following sleeve gastrectomy or Roux-En-Y gastric bypass in a mediterranean population. J Acad Nutr Diet. 2013 Mar;113(3):400-410. doi: 10.1016/j.jand.2012.11.013.
PubMed 23438491Damms-Machado A, Friedrich A, Kramer KM, Stingel K, Meile T, Kuper MA, Konigsrainer A, Bischoff SC. Pre- and postoperative nutritional deficiencies in obese patients undergoing laparoscopic sleeve gastrectomy. Obes Surg. 2012 Jun;22(6):881-9. doi: 10.1007/s11695-012-0609-0.
PubMed 22403000Saif T, Strain GW, Dakin G, Gagner M, Costa R, Pomp A. Evaluation of nutrient status after laparoscopic sleeve gastrectomy 1, 3, and 5 years after surgery. Surg Obes Relat Dis. 2012 Sep-Oct;8(5):542-7. doi: 10.1016/j.soard.2012.01.013. Epub 2012 Feb 1.
PubMed 22398110Ruiz-Tovar J, Oller I, Tomas A, Llavero C, Arroyo A, Calero A, Martinez-Blasco A, Calpena R. Mid-term effects of sleeve gastrectomy on calcium metabolism parameters, vitamin D and parathormone (PTH) in morbid obese women. Obes Surg. 2012 May;22(5):797-801. doi: 10.1007/s11695-011-0582-z.
PubMed 22179702Gehrer S, Kern B, Peters T, Christoffel-Courtin C, Peterli R. Fewer nutrient deficiencies after laparoscopic sleeve gastrectomy (LSG) than after laparoscopic Roux-Y-gastric bypass (LRYGB)-a prospective study. Obes Surg. 2010 Apr;20(4):447-53. doi: 10.1007/s11695-009-0068-4. Epub 2010 Jan 26.
PubMed 20101473Majumder S, Soriano J, Louie Cruz A, Dasanu CA. Vitamin B12 deficiency in patients undergoing bariatric surgery: preventive strategies and key recommendations. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):1013-9. doi: 10.1016/j.soard.2013.04.017. Epub 2013 May 24.
PubMed 24091055Pech N, Meyer F, Lippert H, Manger T, Stroh C. Complications and nutrient deficiencies two years after sleeve gastrectomy. BMC Surg. 2012 Jul 5;12:13. doi: 10.1186/1471-2482-12-13.
PubMed 22765843Eltweri AM, Bowrey DJ, Sutton CD, Graham L, Williams RN. An audit to determine if vitamin b12 supplementation is necessary after sleeve gastrectomy. Springerplus. 2013 May 10;2(1):218. doi: 10.1186/2193-1801-2-218. Print 2013 Dec.
PubMed 23741650
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Vitamin and Mineral Supplementation Post Bariatric Surgery: Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT02817256
- Acronym / sponsor ID
- RCTVMSSG / CRD IRR 430#
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- United Arab Emirates UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A, 'vitamins and minerals' | Active comparator | Dietary Supplement: 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) |
| Group B, 'vitamins and minerals' | Active comparator | Dietary Supplement: 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) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- • Documented severe micronutrient deficiency that require treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamins and MineralsMultivitamins and Minerals supplementation | Dietary supplement | Group A, 'vitamins and minerals', Group B, 'vitamins and minerals' |
Primary outcome
monitor the levels of micronutrients of Iron
Time frame: 1 year
Change in micronutrients level of Iron
8 secondary outcomes
monitor the levels of uric acid
Time frame: 1year
complications resulting from IM injections
Time frame: 1 year
monitor the levels of calcium
Time frame: 1 year
monitor the levels of Vitamin A
Time frame: 1 year
monitor the levels of Vitamin D
Time frame: 1 year
monitor the levels of Serum folate
Time frame: 1 year
monitor the levels of Vitamin B12
Time frame: 1 year
monitor the levels of Serum methyl malonate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Results publication: PubMed 23379892Gariballa S, Afandi B, Abuhaltem M, Yassin J, Habib H, Ibrahim W. Oxidative damage and inflammation in obese diabetic Emirati subjects supplemented with antioxidants and B-vitamins: a randomized placebo-controlled trail. Nutr Metab (Lond). 2013 Feb 4;10(1):21. doi: 10.1186/1743-7075-10-21.
- Results publication: PubMed 24383264Rhines SD, Heins JR. Pharmacotherapy for obesity and weight loss. S D Med. 2013 Nov;66(11):471, 473. No abstract available.
- Results publication: PubMed 17267672Bennett JM, Mehta S, Rhodes M. Surgery for morbid obesity. Postgrad Med J. 2007 Jan;83(975):8-15. doi: 10.1136/pgmj.2006.048868.
- Results publication: PubMed 24122661Coupaye M, Riviere P, Breuil MC, Castel B, Bogard C, Dupre T, Flamant M, Msika S, Ledoux S. Comparison of nutritional status during the first year after sleeve gastrectomy and Roux-en-Y gastric bypass. Obes Surg. 2014 Feb;24(2):276-83. doi: 10.1007/s11695-013-1089-6.
- Results publication: PubMed 19854336Batsis JA, Lopez-Jimenez F, Collazo-Clavell ML, Clark MM, Somers VK, Sarr MG. Quality of life after bariatric surgery: a population-based cohort study. Am J Med. 2009 Nov;122(11):1055.e1-1055.e10. doi: 10.1016/j.amjmed.2009.05.024.
- Results publication: PubMed 25566743Raoof M, Naslund I, Rask E, Karlsson J, Sundbom M, Edholm D, Karlsson FA, Svensson F, Szabo E. Health-Related Quality-of-Life (HRQoL) on an Average of 12 Years After Gastric Bypass Surgery. Obes Surg. 2015 Jul;25(7):1119-27. doi: 10.1007/s11695-014-1513-6.
- Results publication: PubMed 17575749Myers JA, Clifford JC, Sarker S, Primeau M, Doninger GL, Shayani V. Quality of life after laparoscopic adjustable gastric banding using the Baros and Moorehead-Ardelt Quality of Life Questionnaire II. JSLS. 2006 Oct-Dec;10(4):414-20.
- Results publication: PubMed 23438491Moize V, Andreu A, Flores L, Torres F, Ibarzabal A, Delgado S, Lacy A, Rodriguez L, Vidal J. Long-term dietary intake and nutritional deficiencies following sleeve gastrectomy or Roux-En-Y gastric bypass in a mediterranean population. J Acad Nutr Diet. 2013 Mar;113(3):400-410. doi: 10.1016/j.jand.2012.11.013.
- Results publication: PubMed 22403000Damms-Machado A, Friedrich A, Kramer KM, Stingel K, Meile T, Kuper MA, Konigsrainer A, Bischoff SC. Pre- and postoperative nutritional deficiencies in obese patients undergoing laparoscopic sleeve gastrectomy. Obes Surg. 2012 Jun;22(6):881-9. doi: 10.1007/s11695-012-0609-0.
- Results publication: PubMed 22398110Saif T, Strain GW, Dakin G, Gagner M, Costa R, Pomp A. Evaluation of nutrient status after laparoscopic sleeve gastrectomy 1, 3, and 5 years after surgery. Surg Obes Relat Dis. 2012 Sep-Oct;8(5):542-7. doi: 10.1016/j.soard.2012.01.013. Epub 2012 Feb 1.
- Results publication: PubMed 22179702Ruiz-Tovar J, Oller I, Tomas A, Llavero C, Arroyo A, Calero A, Martinez-Blasco A, Calpena R. Mid-term effects of sleeve gastrectomy on calcium metabolism parameters, vitamin D and parathormone (PTH) in morbid obese women. Obes Surg. 2012 May;22(5):797-801. doi: 10.1007/s11695-011-0582-z.
- Results publication: PubMed 20101473Gehrer S, Kern B, Peters T, Christoffel-Courtin C, Peterli R. Fewer nutrient deficiencies after laparoscopic sleeve gastrectomy (LSG) than after laparoscopic Roux-Y-gastric bypass (LRYGB)-a prospective study. Obes Surg. 2010 Apr;20(4):447-53. doi: 10.1007/s11695-009-0068-4. Epub 2010 Jan 26.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salah Gariballa, MD study chair
United Arab Emirates University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamins and Minerals in people with Complications of Other Bariatric Procedure, run by United Arab Emirates University at 2 sites in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jumaa Al Kaabi, MD (+971-371472 ext. 472, j.kaabi@uaeu.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
monitor the levels of micronutrients of Iron (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02817256, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2016.