The effect of vitamin A provided in campaign may depend on vaccination. Observational study from Guinea-Bissau
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1 The effect of vitamin A provided in campaign may depend on vaccination status: Observational study from Guinea-Bissau Ane Bærent Fisker, PhD student Bandim Health Project, Guinea-Bissau & Denmark Dept. of Biostatistics, University of Aarhus
2 WHO recommends Target group Infants 6 to 11 months Children 12 to 59 months Dose IU IU Every 4-6 months in areas where Vitamin A deficiency is a public health problem
3 Vitamin A supplementation (VAS) Mortality Ratio with 95%CI Sommer 1986 Vijayaraghavan 1990 Rahmathullah 1990 West 1991 Daulaire 1992 Herrera 1992 VAST Health 1993 VAST Survival 1993 Dibley 1996 Barreto 1994 Agarval 1995 Venkatarao 1996 Pant 1996 Benn 1997 Donnen 1998 Chowdhury 2002 Subtotal VAS trials VAS to children after 6 months of age reduces overall mortality by 24% Cochrane meta-analysis, Imdad 2010
4 BMJ, August 2011 Mayo-Wilson E et all. BMJ 2011; 343:d5094.
5 Vitamin A supplementation (VAS) Mortality Ratio with 95%CI Sommer 1986 Vijayaraghavan 1990 Rahmathullah 1990 West 1991 Daulaire 1992 Herrera 1992 VAST Health 1993 VAST Survival 1993 Dibley 1996 Barreto 1994 Agarval 1995 Venkatarao 1996 Pant 1996 Benn 1997 Donnen 1998 Chowdhury 2002 Subtotal DEVTA 2007 Total incl. DEVTA VAS trials DEVTA trial: VAS or placebo to 1,000,000 children No benefit of VAS: MRR: 0.96 (95%CI: )
6 Vitamin A supplementation (VAS) Mortality Ratio with 95%CI Sommer 1986 Vijayaraghavan 1990 Rahmathullah 1990 West 1991 Daulaire 1992 Herrera 1992 VAST Health 1993 VAST Survival 1993 Dibley 1996 Barreto 1994 Agarval 1995 Venkatarao 1996 Pant 1996 Benn 1997 Donnen 1998 Chowdhury 2002 Subtotal VAS trials Ghana VAST: MRR 0.81 ( )
7 Ghana VAST, reanalysis VAS/pla acebo Mortality Ratio 1,4 1,2 1 0,8 0,6 0,4 0,2 All Boys Girls P=0.05 P=0.06 P<0.01 VAS/placebo MR 0 Card No card Card No card Card No card The VAS effect differed in children with (N=6,656) and without (N=5,066) a health card (P=0.06) due to differential effect of VAS in girls (P<0.01) Benn et al, AJCN 2009
8 Setting Established in 1978 Two VAS campaigns in urban Guinea- Bissau December 2007 June 2008 Prospective follow up of all children 6-36 months
9 Methods Campaign Next campaign Migration 3 years Death
10 Methods Campaign Next campaign Migration 3 years Death
11 Methods Campaign Next campaign Migration 3 years Death
12 Methods Campaign 2007 Elligible for campaign: living in the Urban BHP area 14 December, 2007 and aged 6-35 months: (n=6026) Available for analysis (n=5567) Excluded: unknown campaign status and censored (n=459): 3 not visited 158 moved before visit 9 died prior to visit 273 completed 3 years prior to visit 11 received VAS in RCT between campaign and visit 5 VAS shortly before the campaign Campaign 2007 status: Received VAS (n=3009) 2739 VAS registered during the campaign 270 VAS registered after campaign Received no VAS (n=2191) Unknown campaign status but followed up (n=367) 297 child and caretaker traveling at all visits 70 informant did not know if the child had received VAS Follow-up status: Dead (n=6) Moved (n=176) 3 years (n=562) VAS in RCT (n=69) Dead (n=8) Moved (n=122) 3 years (n=350) VAS in RCT (n=34) Dead (n=1) Moved (n=36) 3 years (n=20) VAS in RCT (n=0) Campaign 2008 In study 30 June 2008 (n=2196) In study 30 June 2008 (n=1677) In study 30 June 2008 (n=310) Newly added (n=2027) 1561 children born after 14 June newly registered 231 returned to area/excluded in previous campaign Remained in study (n=4183) Elligible for campaign: living in the Urban BHP area 30 June, 2008 and aged 6-35 months: (n=6210) Available for analysis (n=5799) Excluded: unknown campaign status and censored (n=411): 6 not visited 197 moved before visit 17 died prior to visit 154 completed 3 years prior to visit 37 received VAS in RCT between campaign and visit Campaign 2008 status: Received VAS (n=3520) 3167 VAS registered during the campaign 353 VAS registered after campaign Received no VAS (n=1683) Unknown campaign status but followed up (n=596) 521 child and caretaker traveling at all visits 75 informant did not know if the child had received VAS Follow-up status: Dead (n=38) Moved (n=183) 3 years (n=602) VAS in RCT (n=133) Dead (n=12) Moved (n=71) 3 years (n=261) VAS in RCT (n=58) Dead (n=7) Moved (n=59) 3 years (n=70) VAS in RCT (n=8) Followed to 9 January, 2009 (n=2564) Followed to 9 January, 2009 (n=1281) Followed to 9 January, 2009 (n=452)
13 Methods Elligible for campaign: living in the Urban BHP area 14 December, 2007 and aged 6-35 months: (n=6026) Excluded: unknown campaign status and censored (n=459) Available for analysis (n=5567) Campaign 2007 status: Received VAS (n=3009) 2739 VAS registered during the campaign 270 VAS registered after campaign Received no VAS (n=2191) Unknown campaign status but followed up (n=367) 297 child and caretaker traveling at all visits 70 informant did not know if the child had received VAS Followup status: Dead (n=6) Moved (n=176) 3 years (n=562) VAS in RCT (n=69) Dead (n=8) Moved (n=122) 3 years (n=350) VAS in RCT (n=34) Dead (n=1) Moved (n=36) 3 years (n=20) VAS in RCT (n=0) In study 30 June 2008 (n=2196) In study 30 June 2008 (n=1677) In study 30 June 2008 (n=310)
14 Methods Elligible for campaign: living in the Urban BHP area 14 December, 2007 and aged 6-35 months: (n=6026) Excluded: unknown campaign status and censored (n=459) Available for analysis (n=5567) Campaign 2007 status: Received VAS (n=3009) 2739 VAS registered during the campaign 270 VAS registered after campaign Received no VAS (n=2191) Unknown campaign status but followed up (n=367) 297 child and caretaker traveling at all visits 70 informant did not know if the child had received VAS Followup status: Dead (n=6) Moved (n=176) 3 years (n=562) VAS in RCT (n=69) Dead (n=8) Moved (n=122) 3 years (n=350) VAS in RCT (n=34) Dead (n=1) Moved (n=36) 3 years (n=20) VAS in RCT (n=0) In study 30 June 2008 (n=2196) In study 30 June 2008 (n=1677) In study 30 June 2008 (n=310)
15 Methods Elligible for campaign: living in the Urban BHP area 14 December, 2007 and aged 6-35 months: (n=6026) Excluded: unknown campaign status and censored (n=459): Available for analysis (n=5567) Campaign 2007 status: Received VAS (n=3009) 2739 VAS registered during the campaign 270 VAS registered after campaign Received no VAS (n=2191) Unknown campaign status but followed up (n=367) 297 child and caretaker traveling at all visits 70 informant did not know if the child had received VAS Followup status: Dead (n=6) Moved (n=176) 3 years (n=562) VAS in RCT (n=69) Dead (n=8) Moved (n=122) 3 years (n=350) VAS in RCT (n=34) Dead (n=1) Moved (n=36) 3 years (n=20) VAS in RCT (n=0) In study 30 June 2008 (n=2196) In study 30 June 2008 (n=1677) In study 30 June 2008 (n=310)
16 Newly added (n=2027) 1561 children born after 14 June newly registered 231 returned to area/excluded in previous campaign Elligible for campaign: living in the BHP area 30 June, 2008 and aged 6-35 months: (n=6210) Available for analysis (n=5799) Remained in study (n=4183) Methods Excluded: unknown campaign status and censored (n=411) Campaign 2008 status: Followup status: Dead (n=38) Moved (n=183) 3 years (n=602) VAS in RCT (n=133) Received VAS (n=3520) 3167 VAS registered during the campaign 353 VAS registered after campaign Received no VAS (n=1683) Dead (n=12) Moved (n=71) 3 years (n=261) VAS in RCT (n=58) Unknown campaign status but followed up (n=596) 521 child and caretaker traveling at all visits 75 informant did not know if the child had received VAS Dead (n=7) Moved (n=59) 3 years (n=70) VAS in RCT (n=8) Followed to 9 January, 2009 (n=2564) Followed to 9 January, 2009 (n=1281) Followed to 9 January, 2009 (n=452)
17 Newly added (n=2027) 1561 children born after 14 June newly registered 231 returned to area/excluded in previous campaign Campaign 2008 status: Followup status: Dead (n=38) Moved (n=183) 3 years (n=602) VAS in RCT (n=133) Elligible for campaign: living in the BHP area 30 June, 2008 and aged 6-35 months: (n=6210) Available for analysis (n=5799) Received VAS (n=3520) 3167 VAS registered during the campaign 353 VAS registered after campaign Remained in study (n=4183) Received no VAS (n=1683) Dead (n=12) Moved (n=71) 3 years (n=261) VAS in RCT (n=58) Methods Excluded: unknown campaign status and censored (n=411): Unknown campaign status but followed up (n=596) 521 child and caretaker traveling at all visits 75 informant did not know if the child had received VAS Dead (n=7) Moved (n=59) 3 years (n=70) VAS in RCT (n=8) Followed to 9 January, 2009 (n=2564) Followed to 9 January, 2009 (n=1281) Followed to 9 January, 2009 (n=452)
18 Newly added (n=2027) 1561 children born after 14 June newly registered 231 returned to area/excluded in previous campaign Campaign 2008 status: Followup status: Dead (n=38) Moved (n=183) 3 years (n=602) VAS in RCT (n=133) Elligible for campaign: living in the BHP area 30 June, 2008 and aged 6-35 months: (n=6210) Available for analysis (n=5799) Received VAS (n=3520) 3167 VAS registered during the campaign 353 VAS registered after campaign Remained in study (n=4183) Received no VAS (n=1683) Dead (n=12) Moved (n=71) 3 years (n=261) VAS in RCT (n=58) Methods Excluded: unknown campaign status and censored (n=411): Unknown campaign status but followed up (n=596) 521 child and caretaker traveling at all visits 75 informant did not know if the child had received VAS Dead (n=7) Moved (n=59) 3 years (n=70) VAS in RCT (n=8) Followed to 9 January, 2009 (n=2564) Followed to 9 January, 2009 (n=1281) Followed to 9 January, 2009 (n=452)
19 Results - background VAS No VAS P for diff. dist. VAS No VAS Number Sex (Male) 1514 (50) 1096 (50) (51) 861 (51) 0.69 Age at campaign / months (median (interquartile range)) ( ) ( ) 0.10 ( ) ( ) 0.47 Vaccine information Seen vaccination card 2700 (90) 1765 (81) < (88) 1259 (75) <0.001 Last vaccine at the time of the campaign BCG / unvaccinated 13 (0) 11 (1) (1) 15 (1) 0.23 OPV 606 (22) 352 (20) 760 (25) 306 (24) MV 927 (34) 604 (34) 923 (30) 361 (29) DTP 1095 (41) 736 (42) 1311 (42) 540 (43) DTP+MV 62 (2) 62 (4) 76 (2) 37 (3) P for diff. dist.
20 Results - background Socio-economic background VAS No VAS P for diff. dist. VAS No VAS Electricity in the household Yes 854 (28) 634 (29) 1000 (28) 519 (31) No 2130 (71) 1539 (70) 2507 (71) 1154 (69) No information 25 (1) 18 (1) 13 (0) 10 (1) Bathroom Inside the house 417 (14) 322 (15) 495 (14) 276 (16) Outside the house 2560 (85) 1850 (84) 3007 (85) 1395 (83) None 1 (0) 1 (0) 0 (0) 1 (0) No information 31 (1) 18 (1) 18 (1) 11 (1) Type of roofing Straw 122 (4) 75 (3) 119 (3) 48 (3) Hard 2862 (95) 2098 (96) 3389 (96) 1625 (97) No information 25 (1) 18 (1) 12 (0) 10 (1) P for diff. dist.
21 Results - background Socio-economic background VAS No VAS P for diff. dist. VAS No VAS Maternal education <0.001 Any 1988 (66) 1354 (62) 2386 (68) 1000 (59) None 791 (26) 627 (29) 837 (24) 497 (30) No information 230 (8) 210 (10) 297 (8) 186 (11) Ethnic group <0.001 <0.001 Pepel 985 (33) 634 (29) 1067 (30) 456 (27) Fula/Mandinga 602 (20) 619 (28) 759 (22) 534 (32) Manjaco/Mancanha 627 (21) 380 (17) 703 (20) 269 (16) Other 795 (26) 558 (25) 991 (28) 424 (25) P for diff. dist.
22 Results Mortality All Adjusted Mortality Rate Ratio (95% CI)* Rate per 1000 PYRS (Deaths / PYRS) All Boys Girls VAS 15.3 (44 / 2873) 0.78 ( ) 0.73 ( ) 0.89 ( ) No VAS 15.9 (20 / 1260) 1 (ref) 1 (ref) 1 (ref) No information 32.5 (8 / 227) 2.10 ( ) 1.96 ( ) 2.35 ( ) *Adjusted for sex, campaign, seen vaccination card, ethnicity and maternal education
23 Results 2007 Adjusted Mortality Rate Ratio (95% CI)* Rate per 1000 PYRS (Deaths/PYRS) All Boys Girls VAS 4.4 (6 / 1352) 0.38 ( ) 0.52 ( ) 0.16 ( ) No VAS 10.9 (8 / 731) 1 (ref) 1 (ref) 1 (ref) 2008 VAS 24.4 (38 / 1521) 1.02 ( ) 0.86 ( ) 1.32 ( ) No VAS 21.7 (12 / 529) 1 (ref) 1 (ref) 1 (ref) P for same effect of VAS in 2007 and *Adjusted for sex, campaign, seen vaccination card, ethnicity and maternal education
24 Results Campaign information Rate / 1000 PYRS (Deaths/PYRS) Last received vaccine before the campaign OPV VAS 14.1 (8 / 569) No VAS 0 (0 / 203) MV VAS 11.3 (10 / 882) No VAS 26.9 (9 / 335) DTP VAS 20.1 (21 / 1041) No VAS 14.5 (6 / 414) DTP+ MV VAS 16.5 (1 / 61) No VAS 63.3 (2 / 32) MRR (95%CI)* Boys: MRR (95%CI) Girls: MRR (95%CI) P=0.09 P=0.05 P= ( ) 1.29 ( ) 0.31 ( ) 1.37 ( ) 0.21 ( ) 0 NA 0.41 ( ) 1.21 ( ) *Adjusted for sex, campaign, ethnicity and maternal education
25 Results Campaign information Rate / 1000 PYRS (Deaths/PYRS) Last received vaccine before the campaign OPV VAS 14.1 (8 / 569) No VAS 0 (0 / 203) MV VAS 11.3 (10 / 882) No VAS 26.9 (9 / 335) DTP VAS 20.1 (21 / 1041) No VAS 14.5 (6 / 414) DTP+ MV VAS 16.5 (1 / 61) No VAS 63.3 (2 / 32) MRR (95%CI)* Boys: MRR (95%CI) Girls: MRR (95%CI) P=0.09 P=0.05 P= ( ) 1.29 ( ) 0.31 ( ) 1.37 ( ) 0.21 ( ) 0 NA 0.41 ( ) 1.21 ( ) Test of different effect of campaign participation: MV vs OPV: p=0.02; MV vs. DTP: p=0.04 *Adjusted for sex, campaign, ethnicity and maternal education
26 Results Campaign information Rate / 1000 PYRS (Deaths/PYRS) Last received vaccine before the campaign OPV VAS 14.1 (8 / 569) No VAS 0 (0 / 203) MV VAS 11.3 (10 / 882) No VAS 26.9 (9 / 335) DTP VAS 20.1 (21 / 1041) No VAS 14.5 (6 / 414) DTP+ MV VAS 16.5 (1 / 61) No VAS 63.3 (2 / 32) MRR (95%CI)* Boys: MRR (95%CI) Girls: MRR (95%CI) P=0.09 P=0.05 P= ( ) 1.29 ( ) 0.31 ( ) 1.37 ( ) 0.21 ( ) 0 NA 0.41 ( ) 1.21 ( ) Test of different effect of campaign participation: MV vs OPV: p=0.02; MV vs. DTP: p=0.04 *Adjusted for sex, campaign, ethnicity and maternal education
27 Discussion The benefit of VAS may be less than assumed The effect may vary with season in line with a previous study from Bissau, VAS may be beneficial in the dry season but not in the rainy season. The effect may vary by vaccination status. VAS provided after DTP did not reduce mortality.
28 Conclusion The effect of VAS may depend on the vaccination profile in the population The potential interactions between VAS and The potential interactions between VAS and vaccines require further investigation
29 Acknowledgement P. Aaby, C. Bale, I. Balde, S. Biering-Sørensen, J. Agergaard, C. Martins, B.M. Bibby, C.S Benn BHP staff in Bissau Health Centre and EPI Staff in Bissau This work was supported by DANIDA (through grant This work was supported by DANIDA (through grant 104.Dan.8-920), the Danish Medical Research Council, Graduate School of International Health, The Aase and Ejnar Danielsens Foundation, Danish Medical Associations Research foundation and Else and Mogens Wedell-Wedellsborgs Foundation.
30 Thank You! INDEPTH Network
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