Effects on mortality of a nutritional intervention for malnourished HIV-infected adults referred for antiretroviral therapy: a randomised controlled trial

Filteau, Suzanne; PrayGod, George; Kasonka, Lackson; Woodd, Susannah; Rehman, Andrea M; Chisenga, Molly; Siame, Joshua; Koethe, John R; Changalucha, John; Michael, Denna; Kidola, Jeremiah; Manno, Daniela; Larke, Natasha; Yilma, Daniel; Heimburger, Douglas C; Friis, Henrik; Kelly, Paul

doi:10.1186/s12916-014-0253-8

Table 3 Effects of intervention on overall and subgroup mortality

From: Effects on mortality of a nutritional intervention for malnourished HIV-infected adults referred for antiretroviral therapy: a randomised controlled trial

		n	Deaths	Mortality rate per 100 person-years (95% CI)	Rate ratio ^b (95% CI)	P value	P value for modification
Total intention to treat analysis	LNS-VM	914	184	82.6 (71.4–95.4)	0.99 (0.80–1.21)	0.89
Total intention to treat analysis	LNS	901	181	83.7 (72.3–96.8)
Per protocol analysis^a	LNS-VM	356	56	64.2 (49.4–83.4)	0.84 (0.59–1.21)	0.35
Per protocol analysis^a	LNS	354	64	76.9 (60.2–98.2)
Pre-ART period	LNS-VM	896	79	113.6 (91.2–141.7)	1.0 (0.75–1.43)	0.81
	LNS	888	72	108.0 (85.7–136.0)			0.53
Post-ART period	LNS-VM	740	97	64.1 (52.5–78.2)	0.91 (0.69–1.19)	0.49
	LNS	741	105	70.8 (58.5–85.7)
Men	LNS-VM	471	105	94.9 (78.4 to114.9)	0.97 (0.74–1.27)	0.82
	LNS	444	104	97.5 (80.4–118.2)			0.87
Women	LNS-VM	443	79	70.4 (56.4–87.7)	1.00 (0.73–1.37)	0.98
	LNS	457	77	70.2 (56.2–87.8)
Zambia	LNS-VM	559	85	60.8 (49.1–75.2)	0.96 (0.71–1.30)	0.80
	LNS	552	85	63.2 (51.1–78.2)			0.81
Tanzania	LNS-VM	355	99	119.3 (97.9–145.2)	1.01 (0.76–1.34)	0.93
	LNS	349	96	117.3 (96.0–143.3)
BMI <17.0 kg/m²	LNS-VM	542	135	106.8 (90.2–126.4)	1.05 (0.83–1.34)	0.68
	LNS	532	124	101.4 (85.0–120.9)			0.32
BMI ≥17.0 kg/m²	LNS-VM	372	49	50.8 (38.4–67.2)	0.84 (0.57–1.22)	0.36
	LNS	369	57	60.6 (46.8–78.6)
CD4 < 100 /μL	LNS-VM	398	107	117.3 (97.0–141.8)	0.89 (0.69–1.16)	0.39
	LNS	392	117	131.7 (109.9–157.9)			0.22
CD4 ≥ 100 /μL	LNS-VM	516	77	58.5 (46.8–73.1)	1.16 (0.83–1.62)	0.38
	LNS	509	64	50.2 (39.3–64.1)
On TB treatment before ART	LNS-VM	252	38	57.9 (42.2–79.6)	1.30 (0.78–2.16)	0.32
On TB treatment before ART	LNS	199	24	44.3 (29.7–66.1)			0.29
Not on TB treatment before ART	LNS-VM	662	146	92.8 (78.9–109.2)	0.96 (0.76–1.20)	0.71
Not on TB treatment before ART	LNS	702	157	96.8 (82.8–113.2)
Phosphate <0.87 mmol/L	LNS-VM	113	25	93.5 (63.1–138.3)	0.99 (0.54–1.79)	0.96
Phosphate <0.87 mmol/L	LNS	83	19	93.5 (59.6–146.5)			0.998
Phosphate ≥0.87 mmol/L	LNS-VM	775	152	79.8 (68.0–93.5)	0.99 (0.79–1.23)	0.90
Phosphate ≥0.87 mmol/L	LNS	793	154	80.9 (69.1–94.7)
Potassium <3.5 mmol/L	LNS-VM	133	34	113.8 (81.3–159.3)	0.87 (0.55–1.37)	0.54
Potassium <3.5 mmol/L	LNS	141	40	130.3 (95.6–177.7)			0.69
Potassium ≥3.5 mmol/L	LNS-VM	728	137	76.0 (64.3–89.8)	0.96 (0.76–1.22)	0.76
Potassium ≥3.5 mmol/L	LNS	708	136	79.3 (67.1–93.8)

BMI, Body mass index; CI, Confidence interval; LNS, Lipid-based nutritional supplement without added vitamins and minerals; LNS-VM, Lipid nutritional supplement with added vitamins and minerals; TB, Tuberculosis.
^aIncluded only participants who consumed at least 75% of their expected supplement sachets; ^bRate ratio from Cox regression analysis.

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ISSN: 1741-7015

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