Nutritional repletion before bariatric surgery trial

INTERVENTION: 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 Comple XForte 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 CONDITION: Diet and Nutrition ‐ Obesity Obesity;Micronutrient deficiency;Bariatric‐metabolic surgery; ; Obesity ; Micronutrient deficiency ; Bariatric‐metabolic surgery Surgery ‐ Other surgery 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 35.0‐45.0 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. PRIMARY OUTCOME: Participant adherence will be assessed as part of study feasibility: Investigator observation of intervention delivery (infusions and injections), participant self‐report (oral supplements), and pill counting (supplements). Participants will be considered adherent if they accept the infusion or injection if prescribed by the GP and/or if they consume > or = 80% of the recommended oral supplements.[T1: Research treatment phase commences, 2+ weeks prior to the surgery. (Primary timepoint); T3: 4‐14 days post‐surgery.] Retention rate will be assessed as part of study feasibility by an audit of the study recruitment spreadsheet:; Retention rate, expressed as a percentage, will be calculated as: Total number of participants – number of lost participants (withdrawn, removed, lost‐to‐follow‐up) / total number of participants * 100.; ; In addition, the following information will be collected to help describe retention rate, by the audit of the study recruitment spreadsheet and a questionnaire containing one question asking the withdrawal reason.; •Timing, reason, and number of participants who withdraw from the study by T3; ; •timing, reason and number of participants who are removed by the investigators by T2; ; •timing, reasons if possible, and number lost to follow up (not attending study visits or data collection) by T3.[T1: Research treatment phase commences, 2+ weeks prior to the surgery. (Primary timepoint); T2: Day of surgery.; T3: 4‐14 days post‐surgery.] The primary objective of this study is to test the feasibility of the methods. Data collection fidelity of study visits attendance will be assessed as part of study feasibility:; •Number of study visits attended / number required * 100.; Number of study visits attended will be assessed by an audit of the study visit schedule spreadsheet,[Primary outcome will be assessed at the following data collection timepoints:; T0: Baseline.; T1: Research treatment phase commences, 2+ weeks prior to the surgery. (Primary timepoint); T2: Day of surgery.; T3: 4‐14 days post‐surgery.] SECONDARY OUTCOME: Due to the nature of the study (i.e., a pilot), this outcome will be reported as a composite secondary outcome. The preliminary efficacy will be measured by the change in total number of deficiencies of multiple micronutrients (25OHD, thiamin, folate, vitamin B12, ferritin, iron, total iron binding capacity, magnesium, and zinc) between baseline and follow‐ups (at day of surgery, 6‐month post‐surgery, and 12‐month post‐surgery). Blood samples of participants will be collected and analysed by a third‐party accredited laboratory. [T0: baseline, T2: day of surgery, 6‐month post‐surgery, and 12‐month post‐surgery.] Fatigue levels will be assessed via the valid PROMIS Item Bank v1.0 – Fatigue – Short Form 7a tool.[T0: baseline and T3: 4‐14 days post‐surgery.] Quality of life will be measured by the valid and reliable EQ‐5D‐5L.[T0: baseline and T3: 4‐14 days post‐surgery.] Safety will be measured by adverse events expressed by rate, type, and severity. Events will be measured by medical record monitoring and self‐reported safety questionnaire; then categorised by investigators. Examples of adverse events include nausea (type: gastrointestinal, severity: mild), allergic reaction ‐ rash (type: medical, severity: moderate).[Assessed from 14 days prior to the surgery (T1), the day of surgery (T2) and at T3: 4‐14 days post‐surgery.] Sleep quality will be assessed via the valid PROMIS Item Bank v1.0 – Sleep Disturbance – Short Form 8b tool.[T0: baseline and T3: 4‐14 days post‐surgery.] This is a primary outcome. Data collection fidelity of outcome assessment will be assessed as part of study feasibility: ; • Number of missing outcome measures / number required * 100. ; Number of missing outcome measures will be assessed by an audit of data collection tools and the study recruitment spreadsheet. ; [Primary outcome will be assessed at the following data collection timepoints: ; T0: Baseline. ; T1: Research treatment phase commences, 2+ weeks prior to the surgery. (Primary timepoint) ; T2: Day of surgery. ; T3: 4‐14 days post‐surgery. ; ] This is a primary outcome. Intervention fidelity will be assessed as part of study feasibility: The fidelity to the repletion schedule will be measured by comparing actual repletion received against the repletion recommended in the relevant schedule, according to group allocation. Deviated steps will be recorded by investigators in a deviation record (Microsoft Excel spreadsheet). ; • Number of deviations from standard operating procedure (SOP) / total number of steps in SOP * 100 (calculated per participant; measures of central tendency and variation reported).[T0: Baseline. ; T1: Research treatment phase commences, 2+ weeks prior to the surgery. (Primary timepoint) ; T2: Day of surgery. ; T3: 4‐14 days post‐surgery.] This is a primary outcome. Randomisation success will be assessed as part of study feasibility: No statistically significant difference between groups in terms of age, sex, and body mass inde X(BMI).[T0: Baseline.] This is a primary outcome. Recruitment rate will be assessed as part of study feasibility: ; • Total number of participants randomised / the number of months of recruitment time. ; • Participants consented at phase I recruitment / Total number of eligible participants at phase I recruitment * 100. ; • Participants eligible at phase II recruitment / Total number of consented participants at phase I recruitment * 100.[T0: Baseline. ; T1: Research treatment phase commences, 2+ weeks prior to the surgery. (Primary timepoint)]