human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: A r and omized , double-masked trial was carried out in rural Nepal to investigate the incidence and severity of acute side-effects among neonates ( < 1 month of age ) and infants aged 1 - 6 months who received a large , oral dose of vitamin A ( 15,000 retinol equivalents ( RE ) ( 50,000 IU ) and 30,000 RE ( 100,000 IU ) , respectively ) or placebo ( 75 RE ( 250 IU ) and 150 RE ( 500 IU ) , respectively ) in oil . Infants ( vitamin A group , n = 1461 ; controls , n = 1379 ) were assessed for vomiting , loose stools , fever , and irritability during the 24 hours before and after dosing . Fontanelles were palpated 24 hours after dosing . Neonates exhibited no excess risk of adverse side-effects after receiving 15,000 RE . Compared with controls the older infants who ingested 30,000 RE had a 1.6 % excess rate of vomiting ( 95 % confidence interval ( CI ) : 0.2 - 3.0 % ) and a 0.5 % excess rate ( 95 % CI : -0.1 to 1.1 % ) in the occurrence of bulging fontanelles . There were no other significant differences in the older infants . The controlled , periodic distribution of a single 15,000 RE dose of vitamin A therefore confers no apparent acute risk to young infants ; a 30,000 RE dose is associated with a minimum risk of transient , acute side-effects A placebo-controlled trial was carried out among 2067 Indonesian neonates to assess the safety of administering one oral 52-mumol ( 50,000 IU ) dose of vitamin A.  Infants were assessed for potential acute side-effects before and throughout 48 hours after the dose . The first 965 infants were examined by cranial ultrasound before and at 24 hours after dosing to rule out intracranial haemorrhage and determine the resistive index ( RI ) of the anterior cerebral artery using duplex Doppler . Groups were comparable at the baseline . A bulging fontanelle occurred in the control and vitamin A groups , respectively , among 2.7 % and 4.6 % of the infants at 24 hours , and 2.4 % and 4.5 % of the infants at 48 hours . The groups did not differ in any other sign or symptom assessed . No infant developed intracranial haemorrhage . Mean RI values were normal and not different between groups at baseline or at 24 hours . Mean RI fell during the 24 hours , as normally occurs ; the mean decrease was nearly identical in the two groups . A bulging fontanelle was not associated with increased rates of any sign or symptom or with an increase in RI . The 52-mumol dose of oral vitamin A may cause a small increase in intracranial volume in a small proportion of infants , but no increase in intracranial pressure . Acute side-effects following this intervention were rare and mild Objective To investigate the effect of high dose vitamin A supplementation given with BCG vaccine at birth in an African setting with high infant mortality . Design R and omised placebo controlled trial . Setting B and i m Health Project ’s demographic surveillance system in Guinea-Bissau , covering approximately 90 000 inhabitants . Participants 4345 infants due to receive BCG . Intervention Infants were r and omised to 50 000 IU vitamin A or placebo and followed until age 12 months . Main outcome measure Mortality rate ratios . Results 174 children  died during follow-up ( mortality=47/1000 person-years ) . Vitamin A supplementation was not significantly associated with mortality ; the mortality rate ratio was 1.07 ( 95 % confidence interval 0.79 to 1.44 ) . The effect was 1.00 ( 0.65 to 1.56 ) during the first four months and 1.13 ( 0.75 to 1.68 ) from 4 to 12 months of age . The mortality rate ratio in boys was 0.84 ( 0.55 to 1.27 ) compared with 1.39 ( 0.90 to 2.14 ) in girls ( P for interaction=0.10 ) . An explorative analysis revealed a strong interaction between vitamin A and season of administration . Conclusions Vitamin A supplementation given with BCG vaccine at birth had no significant benefit in this African setting . Although little doubt exists that vitamin A supplementation reduces mortality in older children , a global recommendation of supplementation for all newborn infants may not contribute to better survival . Trial registration Clinical trials NCT00168597 Vitamin A deficiency is associated with increased morbidity and mortality from diarrheal disease , measles , and malaria . It has been proposed that vitamin A supplementation could be linked with childhood immunization programs to improve child health . We conducted a r and omized , double‐blind , placebo‐controlled clinical trial to evaluate the impact of linking vitamin A supplementation with the Exp and ed Programme on Immunization on morbidity and child growth .  In West Java , Indonesia , 467 six‐week‐old infants were r and omized to receive 7.5 mg retinol equivalent ( RE ) , 15 mg RE , or placebo with childhood immunization contacts at 6 , 10 , and 14 wks and 9 mo of age . Child growth was assessed through anthropometry , and morbidity histories were obtained . Vitamin A supplementation had no apparent impact upon linear or ponderal growth or infectious disease morbidity in the first 15 mo of age when integrated with the Exp and ed Programme on Immunization The effect of supplementing 11,918 infants < 1 mo and 1 - 5 mo of age with vitamin A ( 15,000 and 30,000 micrograms retinol equivalents or 50,000 and 100,000 IU , respectively ) or a placebo on subsequent 4-mo mortality was assessed in a r and omized , double-masked community trial in the rural plains of Nepal . There were 130 deaths ( 51.6/1000 child-y ) in the control group and 150 deaths ( 57.1/1000 child-y ) in the vitamin A group , yielding a relative risk of 1.11 ( 95 % CI : 0.86 , 1.42 ) , which is indicative of no overall effect on early infant mortality . There was a tendency for the relative risk of mortality among vitamin A recipients to rise with improved nutritional status . These results suggest that distribution of a large oral dose of vitamin A to infants < 5 - 6 mo of age may not benefit short-term survival . This is in contrast with the results of trials in which older infants and children in this same population were supplemented The effects of maternal postpartum vitamin A or beta-carotene supplementation  on  maternal and infant serum retinol concentrations , modified relative dose-response ( MRDR ) ratios and breast milk vitamin A concentrations were assessed during a community-based trial in Matlab , Bangladesh . At 1 - 3 wk postpartum , women were r and omly assigned to receive either ( 1 ) a single dose of 200,000 international units [ 60,000 retinol equivalents ( RE ) ] vitamin A followed by daily placebos ( n = 74 ) , ( 2 ) daily doses of beta-carotene [ 7.8 mg ( 1300 RE ) ] ( n = 73 ) or ( 3 ) daily placebos ( n = 73 ) until 9 mo postpartum . Compared to placebos , vitamin A supplementation result ed in lower maternal MRDR ratios ( i.e. , increased liver stores ) and higher milk vitamin A concentrations at 3 mo , but these improvements were not sustained . The beta-carotene supplementation acted more slowly , result ing in milk vitamin A concentrations higher than the placebo group only at 9 mo . Irrespective of treatment group , over 50 % of women produced milk with low vitamin A concentrations ( < /=1.05 micromol/L or < /=0.28 micromol/g fat ) throughout the study . Overall , mean maternal serum retinol concentrations were not affected by supplementation . Compared to the placebo group , the mean MRDR ratio of 6-mo-old infants was higher in the vitamin A group . Infants ( 33 % ) had serum retinol concentrations < 0.70 micromol/L and 88 % had MRDR ratios > /=0 . 06 . We conclude that while both interventions were beneficial , neither was sufficient to correct the underlying sub clinical vitamin A deficiency in these women nor to bring their infants into adequate vitamin A status It has been suggested that administering vitamin A with the measles vaccine may reduce the vaccine 's immunogenicity . This trial examined the effect of supplementing vitamin A during the early months of life on infants '  immune responses to tetanus and polio vaccines . Young infants ( n = 1085 ) were enrolled and individually r and omized into 1 of 4 groups in a factorial , double-blind , placebo-controlled trial . Three vitamin A supplementation strategies were investigated : 1 ) supplementation of breast-feeding mothers with 60 mg retinol equivalent ( RE ) vitamin A within 4 wk of delivery ; 2 ) Exp and ed Program on Immunization (EPI)-linked supplementation of infants with 7.5 mg RE vitamin A at 6 , 10 , and 14 wk ; and 3 ) combined mother and child supplementations . A 4th group in which mother and child were given placebos served as controls . Blood sample s were collected from each child at 6 wk and 6 mo of age to measure antipolio antibody titer , antitetanus toxoid antibodies , and avidity of antibodies to tetanus . Of the infants r and omized into the 4 arms of the study , 767 ( 71 % ) completed follow-up at 6 mo of age . Follow-up rates were similar in all 4 arms ( 69 - 72 % , P = 0.8 ) . Antibody titers were relatively high in all 4 groups at both 6 wk and 6 mo of age , with no differences among the groups . We found no evidence that vitamin A supplementation affects infants '  antibody responses to tetanus toxoid or oral polio vaccine delivered at EPI contacts BACKGROUND The effect of vitamin A supplementation on the survival of infants aged < 6 mo  is unclear . Because most infant deaths occur in the first few month of life , maternal supplementation may improve infant survival . OBJECTIVES The objective was to assess the effect of maternal vitamin A or beta-carotene supplementation on fetal loss and survival of infants < 6 mo of age . DESIGN Married women of reproductive age in 270 wards of Sarlahi district , Nepal , were eligible to participate . Wards were r and omly assigned to have women receive weekly doses of 7000 microg retinol equivalents as retinyl palmitate ( vitamin A ) , 42 mg all-trans-beta-carotene , or placebo . Pregnancies were followed until miscarriage , stillbirth , maternal death , or live birth of one or more infants , who were followed through 24 wk of age . RESULTS A total of 43559 women were enrolled ; 15832 contributed 17373 pregnancies and 15987 live born infants to the trial . The rate of fetal loss was 92.0/1000 pregnancies in the placebo group , comparable with rates in the vitamin A and beta-carotene groups , which had relative risks of 1.06 ( 95 % CI : 0.91 , 1.25 ) and 1.03 ( 95 % CI : 0.87 , 1.19 ) , respectively . The 24-wk mortality rate was 70.8/1000 live births in the placebo group , comparable with rates in the vitamin A and beta-carotene groups , which had relative risks of 1.05 ( 95 % CI : 0.87 , 1.25 ) and 1.03 ( 95 % CI : 0.86 , 1.22 ) , respectively . CONCLUSIONS Small weekly doses of vitamin A or beta-carotene given to women before conception , during pregnancy , and through 24 wk postpartum did not improve fetal or early infant survival in Nepal At immunization contact , 165 infants 2.5 mo old were r and omly assigned to receive either 15 mg vitamin A ( retinyl palmitate ) or placebo . Three doses were given at monthly intervals with each diphtheria , pertussis , tetanus and oral polio ( DPT/OPV ) immunization dose . The diarrhea and acute respiratory infection ( ARI ) morbidity was similar in the vitamin A and placebo groups . However , the duration ( days per child-year , mean + /- SD ) of ARI was less in the vitamin A group compared with placebo group ( 27.6 + /- 17.1 vs. 40.8 + /- 22.7 ; P = 0.005 ) . Fasting retinol concentrations were measured at entry and in 61 infants , the relative dose response ( RDR ) test was done 1 mo after the third dose of vitamin A. Eighty-five percent of the 
    Output:
    
agent
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: A r and omized , double-masked trial was carried out in rural Nepal to investigate the incidence and severity of acute side-effects among neonates ( < 1 month of age ) and infants aged 1 - 6 months who received a large , oral dose of vitamin A ( 15,000 retinol equivalents ( RE ) ( 50,000 IU ) and 30,000 RE ( 100,000 IU ) , respectively ) or placebo ( 75 RE ( 250 IU ) and 150 RE ( 500 IU ) , respectively ) in oil . Infants ( vitamin A group , n = 1461 ; controls , n = 1379 ) were assessed for vomiting , loose stools , fever , and irritability during the 24 hours before and after dosing . Fontanelles were palpated 24 hours after dosing . Neonates exhibited no excess risk of adverse side-effects after receiving 15,000 RE . Compared with controls the older infants who ingested 30,000 RE had a 1.6 % excess rate of vomiting ( 95 % confidence interval ( CI ) : 0.2 - 3.0 % ) and a 0.5 % excess rate ( 95 % CI : -0.1 to 1.1 % ) in the occurrence of bulging fontanelles . There were no other significant differences in the older infants . The controlled , periodic distribution of a single 15,000 RE dose of vitamin A therefore confers no apparent acute risk to young infants ; a 30,000 RE dose is associated with a minimum risk of transient , acute side-effects A placebo-controlled trial was carried out among 2067 Indonesian neonates to assess the safety of administering one oral 52-mumol ( 50,000 IU ) dose of vitamin A.  Infants were assessed for potential acute side-effects before and throughout 48 hours after the dose . The first 965 infants were examined by cranial ultrasound before and at 24 hours after dosing to rule out intracranial haemorrhage and determine the resistive index ( RI ) of the anterior cerebral artery using duplex Doppler . Groups were comparable at the baseline . A bulging fontanelle occurred in the control and vitamin A groups , respectively , among 2.7 % and 4.6 % of the infants at 24 hours , and 2.4 % and 4.5 % of the infants at 48 hours . The groups did not differ in any other sign or symptom assessed . No infant developed intracranial haemorrhage . Mean RI values were normal and not different between groups at baseline or at 24 hours . Mean RI fell during the 24 hours , as normally occurs ; the mean decrease was nearly identical in the two groups . A bulging fontanelle was not associated with increased rates of any sign or symptom or with an increase in RI . The 52-mumol dose of oral vitamin A may cause a small increase in intracranial volume in a small proportion of infants , but no increase in intracranial pressure . Acute side-effects following this intervention were rare and mild Objective To investigate the effect of high dose vitamin A supplementation given with BCG vaccine at birth in an African setting with high infant mortality . Design R and omised placebo controlled trial . Setting B and i m Health Project ’s demographic surveillance system in Guinea-Bissau , covering approximately 90 000 inhabitants . Participants 4345 infants due to receive BCG . Intervention Infants were r and omised to 50 000 IU vitamin A or placebo and followed until age 12 months . Main outcome measure Mortality rate ratios . Results 174 children  died during follow-up ( mortality=47/1000 person-years ) . Vitamin A supplementation was not significantly associated with mortality ; the mortality rate ratio was 1.07 ( 95 % confidence interval 0.79 to 1.44 ) . The effect was 1.00 ( 0.65 to 1.56 ) during the first four months and 1.13 ( 0.75 to 1.68 ) from 4 to 12 months of age . The mortality rate ratio in boys was 0.84 ( 0.55 to 1.27 ) compared with 1.39 ( 0.90 to 2.14 ) in girls ( P for interaction=0.10 ) . An explorative analysis revealed a strong interaction between vitamin A and season of administration . Conclusions Vitamin A supplementation given with BCG vaccine at birth had no significant benefit in this African setting . Although little doubt exists that vitamin A supplementation reduces mortality in older children , a global recommendation of supplementation for all newborn infants may not contribute to better survival . Trial registration Clinical trials NCT00168597 Vitamin A deficiency is associated with increased morbidity and mortality from diarrheal disease , measles , and malaria . It has been proposed that vitamin A supplementation could be linked with childhood immunization programs to improve child health . We conducted a r and omized , double‐blind , placebo‐controlled clinical trial to evaluate the impact of linking vitamin A supplementation with the Exp and ed Programme on Immunization on morbidity and child growth .  In West Java , Indonesia , 467 six‐week‐old infants were r and omized to receive 7.5 mg retinol equivalent ( RE ) , 15 mg RE , or placebo with childhood immunization contacts at 6 , 10 , and 14 wks and 9 mo of age . Child growth was assessed through anthropometry , and morbidity histories were obtained . Vitamin A supplementation had no apparent impact upon linear or ponderal growth or infectious disease morbidity in the first 15 mo of age when integrated with the Exp and ed Programme on Immunization The effect of supplementing 11,918 infants < 1 mo and 1 - 5 mo of age with vitamin A ( 15,000 and 30,000 micrograms retinol equivalents or 50,000 and 100,000 IU , respectively ) or a placebo on subsequent 4-mo mortality was assessed in a r and omized , double-masked community trial in the rural plains of Nepal . There were 130 deaths ( 51.6/1000 child-y ) in the control group and 150 deaths ( 57.1/1000 child-y ) in the vitamin A group , yielding a relative risk of 1.11 ( 95 % CI : 0.86 , 1.42 ) , which is indicative of no overall effect on early infant mortality . There was a tendency for the relative risk of mortality among vitamin A recipients to rise with improved nutritional status . These results suggest that distribution of a large oral dose of vitamin A to infants < 5 - 6 mo of age may not benefit short-term survival . This is in contrast with the results of trials in which older infants and children in this same population were supplemented The effects of maternal postpartum vitamin A or beta-carotene supplementation  on  maternal and infant serum retinol concentrations , modified relative dose-response ( MRDR ) ratios and breast milk vitamin A concentrations were assessed during a community-based trial in Matlab , Bangladesh . At 1 - 3 wk postpartum , women were r and omly assigned to receive either ( 1 ) a single dose of 200,000 international units [ 60,000 retinol equivalents ( RE ) ] vitamin A followed by daily placebos ( n = 74 ) , ( 2 ) daily doses of beta-carotene [ 7.8 mg ( 1300 RE ) ] ( n = 73 ) or ( 3 ) daily placebos ( n = 73 ) until 9 mo postpartum . Compared to placebos , vitamin A supplementation result ed in lower maternal MRDR ratios ( i.e. , increased liver stores ) and higher milk vitamin A concentrations at 3 mo , but these improvements were not sustained . The beta-carotene supplementation acted more slowly , result ing in milk vitamin A concentrations higher than the placebo group only at 9 mo . Irrespective of treatment group , over 50 % of women produced milk with low vitamin A concentrations ( < /=1.05 micromol/L or < /=0.28 micromol/g fat ) throughout the study . Overall , mean maternal serum retinol concentrations were not affected by supplementation . Compared to the placebo group , the mean MRDR ratio of 6-mo-old infants was higher in the vitamin A group . Infants ( 33 % ) had serum retinol concentrations < 0.70 micromol/L and 88 % had MRDR ratios > /=0 . 06 . We conclude that while both interventions were beneficial , neither was sufficient to correct the underlying sub clinical vitamin A deficiency in these women nor to bring their infants into adequate vitamin A status It has been suggested that administering vitamin A with the measles vaccine may reduce the vaccine 's immunogenicity . This trial examined the effect of supplementing vitamin A during the early months of life on infants '  immune responses to tetanus and polio vaccines . Young infants ( n = 1085 ) were enrolled and individually r and omized into 1 of 4 groups in a factorial , double-blind , placebo-controlled trial . Three vitamin A supplementation strategies were investigated : 1 ) supplementation of breast-feeding mothers with 60 mg retinol equivalent ( RE ) vitamin A within 4 wk of delivery ; 2 ) Exp and ed Program on Immunization (EPI)-linked supplementation of infants with 7.5 mg RE vitamin A at 6 , 10 , and 14 wk ; and 3 ) combined mother and child supplementations . A 4th group in which mother and child were given placebos served as controls . Blood sample s were collected from each child at 6 wk and 6 mo of age to measure antipolio antibody titer , antitetanus toxoid antibodies , and avidity of antibodies to tetanus . Of the infants r and omized into the 4 arms of the study , 767 ( 71 % ) completed follow-up at 6 mo of age . Follow-up rates were similar in all 4 arms ( 69 - 72 % , P = 0.8 ) . Antibody titers were relatively high in all 4 groups at both 6 wk and 6 mo of age , with no differences among the groups . We found no evidence that vitamin A supplementation affects infants '  antibody responses to tetanus toxoid or oral polio vaccine delivered at EPI contacts BACKGROUND The effect of vitamin A supplementation on the survival of infants aged < 6 mo  is unclear . Because most infant deaths occur in the first few month of life , maternal supplementation may improve infant survival . OBJECTIVES The objective was to assess the effect of maternal vitamin A or beta-carotene supplementation on fetal loss and survival of infants < 6 mo of age . DESIGN Married women of reproductive age in 270 wards of Sarlahi district , Nepal , were eligible to participate . Wards were r and omly assigned to have women receive weekly doses of 7000 microg retinol equivalents as retinyl palmitate ( vitamin A ) , 42 mg all-trans-beta-carotene , or placebo . Pregnancies were followed until miscarriage , stillbirth , maternal death , or live birth of one or more infants , who were followed through 24 wk of age . RESULTS A total of 43559 women were enrolled ; 15832 contributed 17373 pregnancies and 15987 live born infants to the trial . The rate of fetal loss was 92.0/1000 pregnancies in the placebo group , comparable with rates in the vitamin A and beta-carotene groups , which had relative risks of 1.06 ( 95 % CI : 0.91 , 1.25 ) and 1.03 ( 95 % CI : 0.87 , 1.19 ) , respectively . The 24-wk mortality rate was 70.8/1000 live births in the placebo group , comparable with rates in the vitamin A and beta-carotene groups , which had relative risks of 1.05 ( 95 % CI : 0.87 , 1.25 ) and 1.03 ( 95 % CI : 0.86 , 1.22 ) , respectively . CONCLUSIONS Small weekly doses of vitamin A or beta-carotene given to women before conception , during pregnancy , and through 24 wk postpartum did not improve fetal or early infant survival in Nepal At immunization contact , 165 infants 2.5 mo old were r and omly assigned to receive either 15 mg vitamin A ( retinyl palmitate ) or placebo . Three doses were given at monthly intervals with each diphtheria , pertussis , tetanus and oral polio ( DPT/OPV ) immunization dose . The diarrhea and acute respiratory infection ( ARI ) morbidity was similar in the vitamin A and placebo groups . However , the duration ( days per child-year , mean + /- SD ) of ARI was less in the vitamin A group compared with placebo group ( 27.6 + /- 17.1 vs. 40.8 + /- 22.7 ; P = 0.005 ) . Fasting retinol concentrations were measured at entry and in 61 infants , the relative dose response ( RDR ) test was done 1 mo after the third dose of vitamin A. Eighty-five percent of the 
    Output:
    