Randomised, double blind, placebo controlled clinical trial of efficacy of vitamin A treatment in non-measles childhood pneumonia

Nacul, Luís; Kirkwood, Betty; Arthur, Paul; Morris, Saul S.; Magalhães, Marcelo; Fink, Maria Cristina Domingues da Silva

doi:10.1136/bmj.315.7107.505

Cited by 56 publications

(40 citation statements)

References 13 publications

(23 reference statements)

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“…This effect is in line with what is known about the role of vitamin A in human immune defence mechanisms (Semba 1994), and with the serological evidence of the extent of vitamin A deficiency among the (Kjolhede et al 1995;Fawzi et al 1996;Kyran et al 1996;Nacul et al 1997). This difference could possibly be due to the extent of vitamin A deficiency among the children in the CHM, while in the Brazil and Guatemala trials (Kjolhede et al 1995;Nacul et al 1997) the prevalence of subclinical vitamin A deficiency was low. Discharge around the 3rd day of hospitalization, coincident with the clinical improvement in vitamin A group described by Nacul et al (1997), may also have contributed to our findings.…”

Section: Discussionsupporting

confidence: 73%

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A randomized, double‐blind, placebo‐controlled clinical trial of vitamin A in Mozambican children hospitalized with nonmeasles acute lower respiratory tract infections

Julien

Gomes

Varandas

et al. 1999

Tropical Med Int Health

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Summaryobjective The objective of this study was to test the potential of routine vitamin A supplementation at admission to speed up recovery during hospitalization for acute lower respiratory tract infections (ALRI) and to decrease the levels of morbidity at 6 weeks after discharge. The study was conducted in the Central Hospital of Maputo (CHM), Mozambique, from 1995 to 1997.methods Children aged 6-72 months with ALRI admitted to the paediatric wards of the CHM were assigned to a supplementation group (n ϭ 71, receiving 200 000 IU of vitamin A) or a control group (n ϭ 93, receiving a placebo).results The prevalence of vitamin A deficiency was very high and similar between the two groups. The median number of inpatient days for the supplementation group was 3, for the placebo group 4 days. On day 5 the rate of clinical discharge was 88.4% (n ϭ 61/69) in the experimental intervention group and 73.9% (n ϭ 65/88) in the placebo group (P ϭ 0.023).conclusion We found a statistically significant reduction in duration of admission among vitamin Asupplemented children with ALRI. This effect is in line with what is known about the role of vitamin A in human defence and immune mechanisms and with the serological evidence of the extent of vitamin A deficiency among the children in this trial.keywords Vitamin A, supplementation, ALRI, RCT, Mocambique correspondence Professor Paulo Ferrinho,

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Section: Discussionsupporting

confidence: 73%

“…Despite the beneficial effect of vitamin A supplementation in measles-related pneumonia (Hussey & Klein 1990;Coutsoudis et al 1991), the results of clinical trials in nonmeasles-related pneumonia have been disappointing (Kjolhede et al 1995;Fawzi et al 1996;Kyran et al 1996;Nacul et al 1997).…”

Section: Introductionmentioning

confidence: 99%

A randomized, double‐blind, placebo‐controlled clinical trial of vitamin A in Mozambican children hospitalized with nonmeasles acute lower respiratory tract infections

Julien

Gomes

Varandas

et al. 1999

Tropical Med Int Health

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“…They all used a placebo group to compare the results and severely malnourished children were most of the time excluded. Except in one study (Julien et al, 1999), no benefits of VA supplementation were reported (Kjolhede et al, 1995;Nacul et al, 1997;Si et al, 1997;Fawzi et al, 1998;Mahalabanis et al, 2004). Adverse effects of high-dose VA were reported in two studies (Stephensen et al, 1998;Fawzi et al, 2000).…”

Section: Discussionmentioning

confidence: 96%

“…In contrast, clinical trials that have examined the effect of high-dose VA supplementation on diarrhoea and respiratory infections in children not infected with measles showed either no effects (Henning et al, 1992;Kjolhede et al, 1995;Nacul et al, 1997;Donnen et al, 1998;Fawzi et al, 1998;Faruque et al, 1999) or only small ones (Dewan et al, 1995;Si et al, 1997;Hossain et al, 1998;Julien et al, 1999).…”

Section: Introductionmentioning

confidence: 99%

Effect of daily low dose of vitamin A compared with single high dose on morbidity and mortality of hospitalized mainly malnourished children in senegal: a randomized controlled clinical trial

et al. 2007

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Background: In vitamin A-deficient populations, children hospitalized with infections and/or malnutrition are at particular risk of developing severe vitamin A (VA) deficiency. High-dose VA supplements are recommended as part of the treatment but results on its effect on recovery from morbidity and on prevention from nosocomial morbidity are conflicting. Objective: We aimed to assess the effect of a single high dose and daily low dose of VA on hospitalized malnourished children's morbidity. Design: We carried out a double-blind, randomized trial in 604 and 610 Senegalese hospitalized children. The first mentioned batch received a high-dose VA supplement (200 000 IU) on admission, the second a daily low-dose VA supplement (5000 IU per day) during hospitalization. Children were followed up until discharged. Data on all-cause morbidity were collected daily. Results: Survival analysis showed that the incidence of respiratory disease was significantly lower in the low-dose group than in the high-dose group, hazard ratios (HR): 0.26, 95% CI: 0.07-0.92. The duration of respiratory infection was also significantly lower in the low-dose group than in the high-dose group (HR of cure: 1.41, 95% CI: 1.05-1.89). Duration and incidence of diarrhoea were not significantly different between treatment groups. In children with oedema on admission, mortality was significantly lower in the low-dose group (Adjusted odds ratio: 0.21; 95% CI: 0.05-0.99). Conclusions: Daily low dose of VA compared with single high dose significantly reduced duration and incidence of respiratory infection but not of diarrhoea in hospitalized children.

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“…35 Experimental animal studies revealed that in situations of deficiency or chronic excess of vitamin A, cellular and humoral immunity are compromised, predisposing to infectious processes. Furthermore, vitamin A supplementation was associated with the absence of effects and even with the presence of adverse effects on the severity of the disease when used as adjuvant therapy for acute respiratory infections, 36 except for morbidities associated with measles. 37 In this regard, this study assumes great importance because it improves the knowledge about the behavior of vitamin A in the infectious process, since there is some evidence that contraindicates the nonjudicious use of vitamin A as prophylaxis or adjuvant therapy for acute respiratory infections.…”

Section: Discussionmentioning

confidence: 99%

Níveis plasmáticos de vitamina A em crianças carentes com pneumonia na fase aguda e após recuperação

Silva¹,

Lopes²,

Sarni³

et al. 2005

J. Pediatr. (Rio J.)

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Suggested citation: da Silva R, Lopes Jr E, Sarni RO, Taddei JA. Plasma vitamin A levels in deprived children with pneumonia during the acute phase and after recovery. J Pediatr (Rio J). 2005;81:162-8. AbstractObjective: The aim of this study was to examine the plasma retinol of children in the acute phase of pneumonia and after recovery and to investigate the association between plasma levels of retinol after recovery with socioeconomic variables, nutritional status and severity of pneumonia.Methods: A prospective cohort study which included 40 low-income hospitalized children with pneumonia, aged 6 months to 5 years. We evaluated: plasma retinol level during the acute phase and after recovery, years of schooling of the head of the family, per capita income, birth weight, nutritional status, hemoglobin levels and severity of pneumonia.Results: Mean plasma retinol levels were significantly higher after recovery than during the acute phase of infection (1.4±0.6 vs. 1.7±0.6 µmol/l, p = 0.03). The frequency of inadequate plasma retinol levels (< 1.05 µmol/l) was 32.5 and 17.5% for the acute phase and after recovery, respectively. There were no statistically significant associations between plasma retinol deficiency and the clinical and epidemiological variables studied. More severe pneumonia was observed in 30/40 (75%) of the patients. There was no statistically significant association between plasma retinol inadequacy after recovery and severity of pneumonia (4/30 13.3% vs. 3/10 30.0%, p = 0.34).Conclusion: Serum retinol levels were significantly higher after recovery than during the acute phase of pneumonia. There was no statistically significant association between the deficiency of serum retinol and the clinical and epidemiological variables studied.J Pediatr (Rio J). 2005;81(2):162-8: Vitamin A, nutritional status, children, pneumonia.

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Randomised, double blind, placebo controlled clinical trial of efficacy of vitamin A treatment in non-measles childhood pneumonia

Cited by 56 publications

References 13 publications

A randomized, double‐blind, placebo‐controlled clinical trial of vitamin A in Mozambican children hospitalized with nonmeasles acute lower respiratory tract infections

A randomized, double‐blind, placebo‐controlled clinical trial of vitamin A in Mozambican children hospitalized with nonmeasles acute lower respiratory tract infections

Effect of daily low dose of vitamin A compared with single high dose on morbidity and mortality of hospitalized mainly malnourished children in senegal: a randomized controlled clinical trial

Níveis plasmáticos de vitamina A em crianças carentes com pneumonia na fase aguda e após recuperação

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