Department of International Health

Newborn Vitamin A Supplementation and Early Infant Mortality:

Current Evidence

James Tielsch, Ph.D.

Bangkok, March 2010

Newborn Vitamin A Supplementation

Background• Vitamin A supplementation well accepted intervention for children 6 – 72 months of age.• Evidence for children <6 m, suggested no impact on child mortality.• Newborn period (first few days) may be different:

• Almost all infants born with very low reserves.• Breastfeeding women often vitamin A deficient.• Trial in very preterm infants in US showed reduced rate of BPD.

Presenter’s Name

Date

Randomized Trials in South and SE Asia

Study Country DesignStudy Size(Live Births)

Age at Dosing

Humphrey et al. (1996)

IndonesiaHospital-based individually randomized trial

Vit. A: 1034Control:1033

Mean = 16.4hrs 88.2% within 24 hrs

Rahmathullah et al. (2003)

IndiaCommunity-based individually randomized trial

Vit. A: 5,786Control: 5,833

Median = 26hrs80% within 48 hrs

Klemm et al. (2009)

BangladeshCommunity-based cluster randomized trial

Vit. A:7.953 Control: 7,984

Median = 7hrs84% within 48 hrs

Bhutta et al.(unfinished)

PakistanCommunity-base cluster randomized trial

Vit. A: 180 clustersCont.: 180 clusters

Not completed

?(unfinished)

India ? ? ?

Presenter’s Name

Date

Randomized Trials in South and SE Asia

Study Country Results

Humphrey et al. (1996) Indonesia RR (IMR) =0.36

(0.16, 0.87)

Rahmathullah et al. (2003)

India RR (6m IMR) = 0.78 (0.63, 0.96)

Klemm et al. (2009) Bangladesh RR (6m IMR) =0.85 (0.73, 1.00)

POOLEDIndia &Bangladesh

RR = 0.83(0.72-0.94)

Presenter’s Name

Date

Pooled Results by Maternal Characteristics

Presenter’s Name

Date

Pooled Results by Infant Characteristics

Presenter’s Name

Date

Randomized Trials in Africa

Two trials in Africa have shown no impact of newborn vitamin A supplementation on early infant mortality.• Zimbabwe (HIV neg infants)

• No maternal vitamin A deficiency.• Very low mortality rates.

• Guinea Bissau• Little vitamin A deficiency• Combined with BCG vaccination• Provided care for sick infants.• Other reasons ???

• Zambia trial just getting started.

• ? SHOULD DATA BE COMBINED WITH ASIAN TRIALS ?

Presenter’s Name

Date

Conclusions

• Trials from Asia provide strong evidence that supplementation with 50,000 IU vitamin A within the first few days after birth reduces early infant mortality in south & southeast Asian settings.

• Waiting until 2 or more weeks after birth will likely have little impact on mortality.

• Newborn vitamin A supplementation is unlikely to have an impact in settings with little maternal vitamin A deficiency and where early infant mortality rates are already low.

• Newborn vitamin A supplementation is a highly cost-effective intervention that can assist countries in meeting MDG-4.