None listed
Conditions
Brief summary
Many patients who have bariatric surgery already have micronutrient (vitamin and mineral) deficiencies before their surgery. However, there is no standard approach to how deficiencies are corrected. This pilot study is conducted to test the feasibility of our methods before conducting a larger study. Participants will be randomised (will not be given a choice) to one of two groups. The intervention group will be referred to a medical practitioner to have their deficiencies treated via infusions and/or injections, alongside multivitamin and calcium tablets for two weeks. The comparator group will receive relevant vitamin and mineral tablets to correct their deficiencies. They will take these tablets, as well as multivitamin and calcium tablets for two weeks. We hypothesise in this pilot study, that a larger study will be feasible to be conducted in a private clinic setting.
Interventions
An intensive preoperative schedule to treat micronutrient deficiencies: patients with low vitamin D level will be referred to a medical practitioner with a recommended treatment of one intramuscular injection of 600,000 IU vitamin D3; patients with low folate level will be referred to a medical practitioner with a recommended treatment of one intramuscular injection of 15 mg folic acid; patients with low iron level (defined by ferritin and transferrin saturation index) will be referred to a medi
An intensive preoperative schedule to treat micronutrient deficiencies: patients with low vitamin D level will be referred to a medical practitioner with a recommended treatment of one intramuscular injection of 600,000 IU vitamin D3; patients with low folate level will be referred to a medical practitioner with a recommended treatment of one intramuscular injection of 15 mg folic acid; patients with low iron level (defined by ferritin and transferrin saturation index) will be referred to a medical practitioner with a recommended treatment of one intravenous infusion of 1 g iron; patients with either solely low thiamin level, solely low vitamin B12 level, or both will be referred to a medical practitioner with a recommended treatment of one intramuscular injection of B-Dose Forte containing 250 mg thiamin and 1 mg vitamin B12 (also containing B2 riboflavin sodium phosphate 5 mg, B3 nicotinamide 50 mg, B5 dexpanthenol 50 mg, B6 pyridoxine hydrochloride 100 mg); patients with solely low magnesium level will be referred to a medical practitioner with a recommended treatment of one intramuscular injection of 480 mg magnesium; patients with solely low zinc level will be referred to a medical practitioner with a recommended treatment of one intramuscular injection of 10.6 mg zinc; patients with low level of B vitamins plus magnesium and/or zinc, will be referred to a medical practitioner with a recommended treatment of one intramuscular injection or intravenous infusion of B Complex Forte with extra magnesium and/or zinc. Referrals for micronutrient infusions or injections will be made at least 14 days prior to sleeve gastrectomy. The referrals will request that in the event the medical practitioner agrees to the recommended infusions and/or injections and they are prescribed, that they are delivered by the medical practitioner (and/or their supervised nurse) 14 days prior to sleeve gastrectomy. Prescription of the recommended treatments by the medical practitioner will be monitored via medical notes and adherence to any prescribed treatments by the medical practitioner will be monitored by the medical notes or direct observation by the researcher. Both the intervention and control arm will orally take one multivitamin and mineral supplement daily, and one calcium supplement daily for 14 days directly prior to sleeve gastrectomy. Multivitamin and mineral supplement contains: beta-carotene 2.3mg, retinol acetate 442.7 µg (vitamin A 375 µg RE), vitamin C 60 mg, cholecalciferol vitamin D3 500 IU, vitamin E 15 IU, thiamin nitrate 6 mg (thiamin 4.9 mg), riboflavin 5 mg, calcium pantothenate 5 mg (vitamin B5 4.6 mg), co-methylcobalamin vitamin B12 300 µg, vitamin B6 as pyridoxine hydrochloride 1.3 mg, calcium folate 347 µg (folic acid 250 µg), vitamin B3 25 mg, vitamin K1 70 µg, inositol 10 mg, iron (as ferrous fumarate) 12 mg, magnesium (as heavy magnesium oxide) 52.5 mg, iodine (as potassium iodide) 75 µg, copper (as cupric citrate hemipentahydrate) 374 µg, zinc (as zinc amino acid chelate) 7.5 mg, selenium (as selenomethionine) 15 µg, manganese (as manganese amino acid chelate) 1 mg, chromium (as chromium picolinate) 25 µg, total chromium 60 µg, choline bitrate 2.5 mg, molybdenum (as molybdenum trioxide) 37.5 µg, biotin 150 µg); Calcium supplement contains: calcium 500 mg, and vitamin D 12.5 µg (equivalent to 500 IU). Adherence to these oral supplements will be measured via interview and tablet/capsule counting at the end of the intervention period. The multivitamin and mineral supplement and calcium supplement is prescribed for 14 days directly prior to sleeve gastrectomy. Medical, diet, and lifestyle conditions recommended as part of usual care will be monitored via medical records and brief participant surveys.
Sponsors
Bond University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Human adults aged 18-65 years. 2. Have elected sleeve gastrectomy as their primary surgery at the recruitment site (a private clinic). 3. Based on a preoperative blood test, has been identified as having at least one of the following micronutrient deficiencies: thiamin, folate, vitamin B12, vitamin D, iron, magnesium, or zinc. 4. BMI 30.0-50.0 kg/m2 2+ weeks prior to surgery. 5. Be willing to accept injection, infusion, and/or oral supplementation as micronutrient repletion strategies. 6. Be willing to stop all non-study related nutritional supplements, herbal preparations, and probiotics from the date of recruitment until Day 1 post-surgery. 7. Be willing to attend three appointments in person at the private clinic: two preoperative and one postoperative appointment. I.e., only local and available participants eligible. 8. 2-week intervention phase is feasible based on eligibility confirmation and surgery date.
Exclusion criteria
1. Medical history of gastrointestinal conditions associated with malabsorption, e.g., coeliac disease, inflammatory bowel disease. 2. Cannot speak, read, or write English. 3. Psychiatric disorder associated with decreased ability to adhere to or tolerate the study conditions, as indicated by the treating psychologist. 4. Patients with known allergy(ies) to vitamin and/or mineral supplementation.
Outcome results
None listed