Lorvand Amiri 2016.
Methods | Randomised clinical trial with parallel group design (3 groups). | |
Participants | 120 participants (38% women), aged 18 to 65 years, mean age 41 years, with NAFLD. Inclusion criteria: BMI 25 kg/m2 to 35 kg/m2, serum 25‐hydroxyvitamin D3 level < 15 ng/mL, reporting a daily calcium intake 700 mg/day to 800 mg/day, and willingness to introduce a dietary change to lose weight. Exclusion criteria: calcium intake < 700 mg/day or > 800 mg/day (in diet or as a supplement); drugs for blood glucose or lipid control; pregnancy or having given birth in the past year or planning a pregnancy in the next 6 months; lactation; weight loss ≥ 10% of body weight within the 6 months before enrolment; participation in competitive sport; abnormal thyroid hormone concentration; intake of medications that could affect body weight or energy expenditure (or both); allergy; smoking; diagnosis of chronic diseases including inflammatory diseases; heart, liver, and renal failure; cancer; acute myocardial infarction; diabetes; stroke; or serious injuries and any other conditions that were not suitable for the trial as evaluated by the physician. |
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Interventions |
Intervention 1: vitamin D 25 μg/day as calcitriol (Jalinus Arya Co., Iran) + calcium carbonate placebo (25 mg/day as lactose; Jalinus Arya Co, Iran) (n = 37). Intervention 2: vitamin D 25 μg/day as calcitriol (Jalinus Arya Co., Iran) + calcium (500 mg/day as calcium carbonate; Jalinus Arya Co., Iran) (n = 37). Control: placebo of calcitriol + placebo of calcium (25 mg/day as lactose; Jalinus Arya Co., Iran) (n = 36). After lunch with a glass of water for 12 weeks. |
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Outcomes |
Primary outcomes: weight loss, body fat, fasting plasma glucose, serum insulin concentrations, lipid profiles, and liver function tests. Secondary outcomes: carbohydrate and lipid metabolism. |
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Stated aim of study | To compare effect of vitamin D supplementation with and without calcium on anthropometric measures and biochemical parameters in people with NAFLD during a weight‐loss programme. | |
Notes | Clinical trial registered at Iranian Registry of Clinical Trials (www.irct.ir) IRCT registration number: IRCT201408312709N29. Trial did not receive any specific grant from funding agencies in the public, commercial, or not‐for‐profit sectors. Additional information received through personal communication with authors on 20 January 2017. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants randomly assigned using computer‐generated random‐numbers method by project co‐ordinator. |
Allocation concealment (selection bias) | Low risk | Participant allocations could not have been foreseen in advance of, or during, enrolment. Allocation controlled by a central and independent randomisation unit. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Products administered by blinded research assistant to blinded participants. Shape, colour, and packaging of placebo similar to supplements in the intervention group. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to assess whether missing data in combination with method used to handle missing data were likely to induce bias. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data were unlikely to make treatment effects depart from plausible values. |
Selective reporting (reporting bias) | Low risk | All predefined outcomes reported fully. |
For‐profit bias | Unclear risk | Trial may or may not have been free of for‐profit bias as no information provided on clinical trial support or sponsorship. |
Other bias | Unclear risk | Trial may or may not have been free of other factors that could put it at risk of bias. |