McClelland 2004 KEN.

Methods	Country: Kenya Setting: outpatient clinics at Coast Provincial General Hospital, Mombasa Duration of recruitment: September 1998 to June 2000 Duration of trial: 22 months Duration of follow‐up: 6 weeks Design: randomized placebo‐controlled trial Follow‐up: at the 6 week follow‐up visit participants underwent a physical examination and bloods and genital tract specimens were collected (as before at baseline)
Participants	Inclusion criteria: women (18 to 45 years) with HIV‐1 infection Exclusion criteria: women who were pregnant or the use of vitamin supplements or oral contraceptives during 3‐month period before study entry Participants screened: 2021 Participants eligible for randomization: 650 Number randomized: 400 (plus 200 participants in vitamin A arm) Mean age: 29 ± 7 years (micronutrient group) versus 29 ± 6 years (placebo group) No participant received ART. It is reported that CD4 cell count and vaginal HIV shedding were higher in the micronutrient group (statistical significance not shown).
Interventions	Intervention: micronutrient supplement (20 mg vitamin B1, 20 mg vitamin B2, 25 mg vitamin B6, 50 µg vitamin B12; 100 mg niacin; 500 mg vitamin C; 30 mg vitamin E; 0.8 mg folic acid; 200 µg selenium) administered as a hard gel capsule daily. Control: placebo (supplement and placebo capsules identical in appearance) Duration: daily for 6 weeks Compliance: reported as the proportion of participants in each treatment group who took 95% of scheduled doses (micronutrient group: 93.7% (168/179); control group: 92.1% (164/178). Supplements were dispensed with an electronic alarm vial.
Outcomes	Primary outcomes: vaginal and cervical HIV‐1 shedding Secondary outcomes: CD4, CD8 cell count, viral load
Adverse events	Multivitamin supplementation increased cervical and vaginal shedding of HIV‐positive cells
Notes	Source of funding: National Institutes of Health and University of Washington Clinical Nutrition Research Unit Conflict of interest: statement not included Ethics: University of Nairobi, University of Washington Trial registration: not specified
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The trial used computer‐generated randomization sequence in blocks.
Allocation concealment (selection bias)	Unclear risk	It was unclear who was responsible for the allocation of treatment (sequential numbering of medication bottles not specified).
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Blinding was not specified except for participants who received identical capsules.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Twenty‐one(10.5%) and 22(11%) participants were lost to follow‐up from the multivitamin and placebo groups respectively. However, the trial authors did not state the reasons for loss to follow‐up. Participants who were lost to follow‐up had lower CD4 cell counts compared to those who completed the trial, but cell counts were not reported for each treatment group.
Selective reporting (reporting bias)	Unclear risk	The trial protocol was not available
Other bias	Unclear risk	The trial authors did not provide any statement regarding conflicts of interest.