Background
Methods
Study design
Setting
Recruitment and enrollment
Randomization
ACTIVITY | −30 to −7 Days | BASELINE | M1 | M2 | M3 | M4 | M5 | M6 | M7 | M8 | M9 | M10 | M11 | M12 | M13 | M14 | M15 | M16 | M17 | M18 |
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I. CASE REPORT FORMS
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Pre-Eligibility Assessment |
X
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Eligibility Confirmation & Informed Consent |
X
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Enrollment & Randomization |
X
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Contact Information |
X
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Drug Regimen Refill of @ monthly clinic visits |
X
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X
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X
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X
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X
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X
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X
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X
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X
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X
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X
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X
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X
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X
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X
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X
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X
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X
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X
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Background Questionnaire |
X
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Health Assessment Questionnaire |
X
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X
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X
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X
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X
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FFQ |
X
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X
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X
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X
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QoL Questionnaire |
X
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X
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X
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X
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Weight |
X
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X
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X
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X
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II. LAB TESTS
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CD4 |
X
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X
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X
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X
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X
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CBC |
X
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X
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X
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X
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Malaria Parasitemia |
X
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X
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X
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X
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Helminth Infections |
X
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X
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X
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X
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ALT |
X
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X
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X
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X
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Urine Dipstick |
X
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X
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X
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X
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III. SAMPLES FOR STORAGE
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Lipid profile (HDL, LDL, Triglyceride) |
X
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X
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X
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X
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Sample storage for cytokine Elisa (IL2, IL4, IL5, IL6, IL10, IL12, TNF-a, IFN-γ) |
X
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X
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X
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X
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Sample storage for Hep B, Hep C, D4T & Vitamin D levels |
X
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X
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X
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X
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Measurements
Clinical parameters
Nutritional assessment
Dietary intake
Laboratory investigations
Study outcomes
Statistical issues
Statistical power
Mean difference in CD4 change (δ, in cells/mm3) | Standard deviation of CD4 counts at baseline and follow-up (σ1 = σ2, in cells/mm3) | Correlation of CD4 counts between baseline and follow-up (ρ) | ||
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0.5 | 0.6 | 0.7 | ||
40 | 175 | 58 | 68 | 80 |
225 | 39 | 47 | 59 | |
50 | 175 | 77 | 86 | 94 |
225 | 56 | 66 | 78 | |
60 | 175 | 90 | 95 | 99 |
225 | 72 | 81 | 90 | |
70 | 175 | 97 | 99 | >99 |
225 | 84 | 91 | 97 |
Mean difference in weight change (δ, in kg) | Standard deviation of weight at baseline and follow-up (σ1 = σ2, in cells/mm3) | Correlation of weight between baseline and follow-up (ρ) | ||
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0.5 | 0.6 | 0.7 | ||
2 | 9 | 56 | 66 | 78 |
11 | 41 | 49 | 61 | |
2.5 | 9 | 75 | 88 | 96 |
11 | 58 | 74 | 86 | |
3 | 9 | 88 | 94 | 98 |
11 | 74 | 82 | 92 | |
3.5 | 9 | 96 | 98 | >99 |
11 | 86 | 92 | 97 |