Effect of vitamin A supplementation in women of reproductive age on maternal survival in Ghana (ObaapaVitA): a cluster-randomised, placebo-controlled trial

The Lancet ◽  
2010 ◽  
Vol 375 (9726) ◽  
pp. 1640-1649 ◽  
Author(s):  
Betty R Kirkwood ◽  
Lisa Hurt ◽  
Seeba Amenga-Etego ◽  
Charlotte Tawiah ◽  
Charles Zandoh ◽  
...  
2016 ◽  
Vol 102 (3) ◽  
pp. 216-223 ◽  
Author(s):  
Sajid Soofi ◽  
Shabina Ariff ◽  
Kamran Sadiq ◽  
Atif Habib ◽  
Zaid Bhatti ◽  
...  

BackgroundDespite evidence for the benefits of vitamin A supplementation (VAS) among children 6 to 59 months of age, the feasibility of introduction and potential benefit of VAS in the neonatal period in public health programmes is uncertain.ObjectiveThe primary objective was to evaluate the feasibility and effectiveness of early neonatal VAS (single dose of 50 000 international units within 48–72 hours after birth) delivered through the public sector Lady Health Worker (LHW) programme in rural Pakistan and to document its association with a reduction in mortality at 6 months of age.MethodsA community-based, cluster randomised, placebo-controlled trial was undertaken in two districts of rural Pakistan. LHWs dispensed vitamin A/placebo in identical capsules to newborn infants within 48–72 hours of birth. Follow-up visits were undertaken at 1 week of age and every 4 weeks thereafter until 6 months of age.ResultsOf a total of 15 433 consecutive pregnancies among eligible women of reproductive age, 13 225 pregnancies were registered, 12 218 live births identified and 11 028 newborn infants reached by LHWs. Of these, 5380 (49%) received neonatal VAS and 5648 (51%) placebo. The LHWs successfully delivered the capsules to 79% of newborns within 72 hours of birth with no significant adverse effects. Although the proportion of days observed with symptoms of fever, diarrhoea or rapid breathing were lower with neonatal VAS, these differences were not statistically significant. Mortality rates in the two groups were comparable at 6 months of age.ConclusionsWhile our study demonstrated that neonatal VAS was safe and could be feasibly delivered by LHWs in Pakistan as part of their early postnatal visits, the overall lack of benefit on neonatal and 6-month morbidity and mortality in our population suggests the need for further evaluation of this intervention in populations at risk.Trial registration numberClinicalTrials.gov NCT00674089.


2021 ◽  
Vol 2021 (1) ◽  
Author(s):  
S van Wessel ◽  
T Hamerlynck ◽  
V Schutyser ◽  
C Tomassetti ◽  
C Wyns ◽  
...  

Abstract STUDY QUESTIONS Does the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth? WHAT IS KNOWN ALREADY Intrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality. STUDY DESIGN, SIZE, DURATION This multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%. PARTICIPANTS/MATERIALS, SETTING, METHODS Women of reproductive age (18–47 years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6 weeks after receiving allocated treatment with follow-up ending at 30 weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2–6 weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30 weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30 weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester. STUDY FUNDING/COMPETING INTEREST(S) This work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest.


2007 ◽  
Vol 98 (2) ◽  
pp. 422-430 ◽  
Author(s):  
R. A. Ayah ◽  
D. L. Mwaniki ◽  
P. Magnussen ◽  
A. E. Tedstone ◽  
T. Marshall ◽  
...  

Postpartum vitamin A supplementation of mothers and infants is recommended, but the efficacy has been questioned. In this double-blind, placebo-controlled trial, Kenyan mother–infant pairs were randomised to maternal vitamin A (400 000 IU) or placebo < 24 h postpartum, and infant vitamin A (100 000 IU) or placebo at 14 weeks. Milk retinol was determined at weeks 4, 14 and 26, and maternal and infant serum retinol at weeks 14 and 26. Infant retinol stores were assessed at week 26, using a modified relative dose response (MRDR) test. Among 564 women, serum retinol at 36 weeks gestation was 0·81 (sd 0·21) μmol/l, and 33·3 % were < 0·7 μmol/l. Maternal serum retinol was not different between groups, but milk retinol was higher in the vitamin A group: (0·67 v. 0·60 μmol/l; 0·52 v. 0·44 μmol/l; 0·50 v. 0·44 μmol/l at 4, 14 and 26 weeks, respectively). When expressed per gram fat, milk retinol was higher in the vitamin A group only at 4 weeks. Infant serum retinol was not different between groups. However, although most infants had deficient vitamin A stores (MRDR>0·06 %) at 26 weeks, vitamin A to infants, but not mothers, resulted in a lower proportion of infants with deficient vitamin A stores (69 v. 78 %). High-dose postpartum vitamin A supplementation failed to increase serum retinol and infant stores, despite modest effects on milk retinol. Infant supplementation, however, increased stores. There is a need for a better understanding of factors affecting absorption and metabolism of vitamin A.


The Lancet ◽  
2015 ◽  
Vol 385 (9975) ◽  
pp. 1324-1332 ◽  
Author(s):  
Honorati Masanja ◽  
Emily R Smith ◽  
Alfa Muhihi ◽  
Christina Briegleb ◽  
Salum Mshamu ◽  
...  

2020 ◽  
Vol 8 (2) ◽  
pp. 1-11
Author(s):  
Mane Hélène Faye ◽  
Nicole Idohou-Dossou ◽  
Abdou Badiane ◽  
Anta Agne-Djigo ◽  
Papa Mamadou DD Sylla ◽  
...  

Background: Like many developing countries, Senegal does not have data on the extent of vitamin A deficiency (VAD) that is representative of its population. The present survey was conducted to fill this gap and to identify factors associated with VAD, prior to the introduction of a large-scale vitamin A oil fortification program. Procedures: A nationwide representative cross-sectional survey involving 1887 children 12 to 59 months old and 1316 women of reproductive age (WRA) was conducted. Blood samples were collected and plasma concentrations of retinol (PR), C-reactive protein (CRP), and alpha-1-acidglycoprotein were measured. PR was adjusted for subclinical inflammation using the BRINDA regression methodology. Multivariate logistic regression was used to identify factors associated with VAD. Findings: The adjusted prevalence of VAD (PR ≤ 0.7 μmol/L) in children was 15.3% and differed by age group, area of residence, and socioeconomic status and half of them had subclinical inflammation. Among WRA, VAD was low (2.3%) and 18.1% had vitamin A insufficiency (VAI). Pregnant women were more affected by VAI (28.4%) and Dakar had lower figures compared with other cities and rural strata. Prevalence of VAI decreased with increasing wealth quintile. In logistic regression, abnormal CRP, poverty, scarce consumption of poultry, oysters, melon, red palm oil, palm kernel oil, Saba senegalensis fruit pulp (Maad) and cowpea, frequent consumption of leeks and consumption of Leptadenia hastata leaves (Mbuum tiakhat), were associated with VAD in children. For women, lower socioeconomic status, fair or poor health status and anemia were negatively associated with VAI. Conclusions: In Senegal, VAD is a moderate public health problem in children and slight among women. Particular attention should be paid to children older than 23 months, pregnant women, rural populations, and poorest households. Nutritional interventions should be implemented alongside morbidity prevention and control. Keywords: vitamin A deficiency, children 12-59 months, women of reproductive age, Senegal.


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