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. 2014 Nov 14;6(11):5117–5141. doi: 10.3390/nu6115117

Table 2.

Validity Characteristics of included studies.

Study Selection Bias or Detection Bias Performance or Detection Bias Attrition Bias Controlled Variables Reviewer Notes/Possible Limitations
Bruner et al., 1996 [16] Randomization clear, double-blinded design Researchers and participants blinded to allocation Not all randomized included in outcomes; dropouts and reasons for dropouts reported Additional vitamins and minerals All participants had ID. There was no measurement of baseline differences between iron-sufficient and ID adolescents. Serum ferritin was a marker of iron status. Statistical analysis was by group assignment, rather than ferritin response.
Beard et al., 2005 [21] Randomization clear, double-blinded design Participants unaware of group allocation Intention-to-treat protocol utilized to deal with missing data; dropouts reported; however, reasons for dropouts not reported Age, socioeconomic status, income, education, nutritional intakes Staff members administered supplementations at health clinics with instructions for the mothers on when to take and when to return, etc. Standardized outcome measures were used.
Murray-Kolb and Beard, 2007 [2] Randomization clear, double-blind placebo-controlled design One researcher knew the group allocation; outcome assessors, as well as participants were blinded to group allocation Not all of those randomized included in outcomes; dropout rates reported; however, reasons for dropouts not reported Socioeconomic status, grade point average, level of physical activity and other demographics;other vitamins/minerals; inflammation, contraception and menstrual cycle; intellectual ability (IQ) was used as a covariate Standardized and validated measures of were cognition used. High reliability. Analysis was completed on women who were classified as ferritin responders or non-responders. Determination of the relationship between changes in iron status and changes in cognition. 16 weeks used to allow more time for brain iron concentrations to replenish.
McClung et al., 2009 [16] Randomization reported, double-blind, placebo-controlled design Researchers, outcome assessors and participants all blinded to allocation Unclear if all of those randomized included in outcomes; dropout rates and reasons for dropouts reported Compliance monitored and assessed as a confounding variable. Research assistants administered capsules to participants each day. Treatment occurred on the background of battle combat training. Randomization procedures were not described.
Verdon et al., 2003 [24] Randomization clear, double-blind design Researchers, outcome assessors and participants blind to allocation Intention-to-treat protocol completed to deal with missing data; dropout rates recorded and reasons for dropout recorded Other disorders that could explain fatigue Intervention period was relatively shorter than other included studies. A validated self-administered questionnaire was used, although fatigue was assessed on a visual analogue scale. Adherence to treatment was monitored by an electronic device that recorded the date and time that the pill container was opened
Vaucher et al., 2012 [22] Multi-centre study, randomization clear, double-blind, placebo-controlled design Researchers, outcome assessors and participants blinded to allocation Intention-to-treat protocol completed to deal with missing data A validated self-administered questionnaire used. Intention-to-treat analysis was used, and attrition and compliance were less of an issue. Dropout rates were not reported
Lambert et al., 2002 [23] Randomization occurred, but allocation procedures not described Researcher and participants blinded to allocation Unclear if randomized participants included in outcomes/dropout rates reported/reasons for dropouts reported Standardized and validated outcome measures were used.
Devaki et al., 2009 [20] No randomization described No blinding methods described Unclear if randomized participants included in outcomes; dropout rates and reasons for dropout reported Compliance was monitored as supplements were administered by a supervisor at breakfast and lunch. Potential for performance, selection and detection bias.
Siwek et al., 2009 [17] Randomization clear Researchers and participants blinded to allocation Outpatient sample.
Nowak et al., 2003 [18] Randomization described Researchers and participants blinded to allocation Unclear if randomized participants included in outcome; dropout rates reported however reasons for dropout not reported Clinical sample, so it is difficult to generalize to wider population. Standardized and validated measures of depressive symptoms were used. Allocation procedures were not described.
Sawada and Yokoi, 2010 [19] Randomization clear, A double-blind, double-blinded, placebo-controlled design Researchers and participants blinded to allocation Information around dropout rates and missing data was not reported Age, height, body mass, body weight Pilot study, first of its kind. There are missing data and information around how this was dealt with. Treatment was possibly confounded by the use of multivitamins, alongside zinc