Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial
<p>Abstract</p> <p>Background</p> <p>Vitamin A supplementation of 6-59 month old children is currently recommended by the World Health Organization based on evidence that it reduces mortality. There has been considerable interest in determining the benefits of neonatal...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2012-02-01
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| Series: | Trials |
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| Online Access: | http://www.trialsjournal.com/content/13/1/22 |
| _version_ | 1818346830571765760 |
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| author | Bahl Rajiv Bhandari Nita Dube Brinda Edmond Karen Fawzi Wafaie Fontaine Olivier Kaur Jasmine Kirkwood Betty R Martines Jose Masanja Honorati Mazumder Sarmila Msham Salum Newton Sam Oleary Maureen Ruben Julia Shannon Caitlin Smith Emily Taneja Sunita Yoshida Sachiyo |
| author_facet | Bahl Rajiv Bhandari Nita Dube Brinda Edmond Karen Fawzi Wafaie Fontaine Olivier Kaur Jasmine Kirkwood Betty R Martines Jose Masanja Honorati Mazumder Sarmila Msham Salum Newton Sam Oleary Maureen Ruben Julia Shannon Caitlin Smith Emily Taneja Sunita Yoshida Sachiyo |
| author_sort | Bahl Rajiv |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Vitamin A supplementation of 6-59 month old children is currently recommended by the World Health Organization based on evidence that it reduces mortality. There has been considerable interest in determining the benefits of neonatal vitamin A supplementation, but the results of existing trials are conflicting. A technical consultation convened by WHO pointed to the need for larger scale studies in Asia and Africa to inform global policy on the use of neonatal vitamin A supplementation. Three trials were therefore initiated in Ghana, India and Tanzania to determine if vitamin A supplementation (50,000 IU) given to neonates once orally on the day of birth or within the next two days will reduce mortality in the period from supplementation to 6 months of age compared to placebo.</p> <p>Methods/Design</p> <p>The trials are individually randomized, double masked, and placebo controlled. The required sample size is 40,200 in India and 32,000 each in Ghana and Tanzania. The study participants are neonates who fulfil age eligibility, whose families are likely to stay in the study area for the next 6 months, who are able to feed orally, and whose parent(s) provide informed written consent to participate in the study. Neonates randomized to the intervention group receive 50,000 IU vitamin A and the ones randomized to the control group receive placebo at the time of enrolment. Mortality and morbidity information are collected through periodic home visits by a study worker during infancy. The primary outcome of the study is mortality from supplementation to 6 months of age. The secondary outcome of the study is mortality from supplementation to 12 months of age. The three studies will be analysed independent of each other. Subgroup analysis will be carried out to determine the effect by birth weight, sex, and timing of DTP vaccine, socioeconomic groups and maternal large-dose vitamin A supplementation.</p> <p>Discussion</p> <p>The three ongoing studies are the largest studies evaluating the efficacy of vitamin A supplementation to neonates. Policy formulation will be based on the results of efficacy of the intervention from the ongoing randomized controlled trials combined with results of previous studies.</p> <p>Trial Registration</p> <p><b>Ghana: </b>Australian New Zealand Clinical Trials Registry (ANZCTR) - <a href="http://www.anzctr.org.au/ACTRN12610000582055.aspx">ACTRN12610000582055</a><b>; India: </b>CLINICALTRIALS.GOV - <a href="http://www.clinicaltrials.gov/ct2/show/NCT01138449">NCT01138449</a><b>; Tanzania: </b>Australian New Zealand Clinical Trials Registry (ANZCTR) - <a href="http://www.anzctr.org.au/ACTRN12610000636055.aspx">ACTRN12610000636055</a>.</p> |
| first_indexed | 2024-12-13T17:24:30Z |
| format | Article |
| id | doaj.art-3e8c091dd8e94cffa167c37f408b6e4f |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-13T17:24:30Z |
| publishDate | 2012-02-01 |
| publisher | BMC |
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| series | Trials |
| spelling | doaj.art-3e8c091dd8e94cffa167c37f408b6e4f2022-12-21T23:37:13ZengBMCTrials1745-62152012-02-011312210.1186/1745-6215-13-22Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trialBahl RajivBhandari NitaDube BrindaEdmond KarenFawzi WafaieFontaine OlivierKaur JasmineKirkwood Betty RMartines JoseMasanja HonoratiMazumder SarmilaMsham SalumNewton SamOleary MaureenRuben JuliaShannon CaitlinSmith EmilyTaneja SunitaYoshida Sachiyo<p>Abstract</p> <p>Background</p> <p>Vitamin A supplementation of 6-59 month old children is currently recommended by the World Health Organization based on evidence that it reduces mortality. There has been considerable interest in determining the benefits of neonatal vitamin A supplementation, but the results of existing trials are conflicting. A technical consultation convened by WHO pointed to the need for larger scale studies in Asia and Africa to inform global policy on the use of neonatal vitamin A supplementation. Three trials were therefore initiated in Ghana, India and Tanzania to determine if vitamin A supplementation (50,000 IU) given to neonates once orally on the day of birth or within the next two days will reduce mortality in the period from supplementation to 6 months of age compared to placebo.</p> <p>Methods/Design</p> <p>The trials are individually randomized, double masked, and placebo controlled. The required sample size is 40,200 in India and 32,000 each in Ghana and Tanzania. The study participants are neonates who fulfil age eligibility, whose families are likely to stay in the study area for the next 6 months, who are able to feed orally, and whose parent(s) provide informed written consent to participate in the study. Neonates randomized to the intervention group receive 50,000 IU vitamin A and the ones randomized to the control group receive placebo at the time of enrolment. Mortality and morbidity information are collected through periodic home visits by a study worker during infancy. The primary outcome of the study is mortality from supplementation to 6 months of age. The secondary outcome of the study is mortality from supplementation to 12 months of age. The three studies will be analysed independent of each other. Subgroup analysis will be carried out to determine the effect by birth weight, sex, and timing of DTP vaccine, socioeconomic groups and maternal large-dose vitamin A supplementation.</p> <p>Discussion</p> <p>The three ongoing studies are the largest studies evaluating the efficacy of vitamin A supplementation to neonates. Policy formulation will be based on the results of efficacy of the intervention from the ongoing randomized controlled trials combined with results of previous studies.</p> <p>Trial Registration</p> <p><b>Ghana: </b>Australian New Zealand Clinical Trials Registry (ANZCTR) - <a href="http://www.anzctr.org.au/ACTRN12610000582055.aspx">ACTRN12610000582055</a><b>; India: </b>CLINICALTRIALS.GOV - <a href="http://www.clinicaltrials.gov/ct2/show/NCT01138449">NCT01138449</a><b>; Tanzania: </b>Australian New Zealand Clinical Trials Registry (ANZCTR) - <a href="http://www.anzctr.org.au/ACTRN12610000636055.aspx">ACTRN12610000636055</a>.</p>http://www.trialsjournal.com/content/13/1/22Vitamin Aneonatalinfant mortalityrandomized controlled trial |
| spellingShingle | Bahl Rajiv Bhandari Nita Dube Brinda Edmond Karen Fawzi Wafaie Fontaine Olivier Kaur Jasmine Kirkwood Betty R Martines Jose Masanja Honorati Mazumder Sarmila Msham Salum Newton Sam Oleary Maureen Ruben Julia Shannon Caitlin Smith Emily Taneja Sunita Yoshida Sachiyo Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial Trials Vitamin A neonatal infant mortality randomized controlled trial |
| title | Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial |
| title_full | Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial |
| title_fullStr | Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial |
| title_full_unstemmed | Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial |
| title_short | Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial |
| title_sort | efficacy of early neonatal vitamin a supplementation in reducing mortality during infancy in ghana india and tanzania study protocol for a randomized controlled trial |
| topic | Vitamin A neonatal infant mortality randomized controlled trial |
| url | http://www.trialsjournal.com/content/13/1/22 |
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