Vitamin A Deficiency Clinical Trial
Official title:
Randomised Double-blind Placebo-controlled Trial to Evaluate the Impact of Vitamin A on Maternal Mortality in Ghana
Main objectives: To evaluate the impact of weekly vitamin A supplementation (VAS) to women of
reproductive age (15-45 years) on maternal mortality in rural Ghana, and to compare this with
the impact on overall mortality.
Hypotheses:
1. Weekly supplementation with vitamin A (7000 µg retinol equivalent [RE]) to reproductive
age women will reduce maternal deaths by 33%.
2. This impact will be achieved by reductions in both pregnancy-related and
non-pregnancy-related deaths.
3. There will be a reduction in non-maternal deaths, similar in size to that in maternal
non-pregnancy related deaths.
Outcome measures: Maternal mortality rate, and overall mortality rate. Deaths will be
identified through monthly demographic surveillance, and classified as maternal
(pregnancy-related, non-pregnancy-related) or non-maternal using verbal autopsies.
Pregnancy accounts for nearly 600,000 deaths of women each year; maternal health problems are
the largest contributors to the disease burden of adult women. Conventional primary health
care approaches, which included Traditional Birth Attendant training and antenatal screening,
had little impact on the maternal mortality ratio. Instead, the Safe Motherhood paradigm now
aims to ensure emergency obstetric care (EMOC) at the district hospital level for the 10-15%
of women who develop potentially life threatening complications, and is moving towards
recommending that professionals attend all deliveries.
While the latter configurations of care have been shown to reduce maternal mortality, they
require considerable political will, attention to health systems, and expansion of access to
supervised delivery and EMOC. For the poorest countries, such capacity is some years down the
line. Low-tech interventions which effectively reduce maternal mortality, and which can be
delivered at the community level would be a welcome addition to the armamentarium of public
health measures for preventing maternal mortality. Should vitamin A supplementation prove to
be effective in reducing maternal mortality, or indeed all-cause female mortality, it would
provide such a tool. Moreover, as there is considerable policy and programmatic interest in
VAS for children, it is likely that such interest can be broadened to encompass
supplementation for women. Furthermore, it is increasingly recognised that poverty not only
increases the risk of ill health, but that ill health in turn plays a major role in creating
and perpetuating poverty. A community-based intervention such as Vitamin A is likely to
address the needs of the very poorest women, as these are the individuals least likely to
have access to emergency obstetric care and professional birth attendants.
This will be a cluster-randomised double-blind placebo-controlled trial. All women between
the ages of 15 and 45 years will be randomised, according to their cluster of residence to
receive weekly capsules of either 7000 RE of vitamin A in peanut oil or identical looking
placebo capsules containing peanut oil only. Thus, supplements will be delivered to women
both in antenatal and inter-pregnancy periods.
The trial will be conducted by the Kintampo Health Research Centre (KHRC) in four contiguous
districts - Kintanpo, Techiman, Wenchi and Nkoranza -- in the Brong Ahafo region of Ghana.
The districts fall within the forest-savannah transitional ecological zone, and vitamin A
rich food sources are less available than in the forest regions to the south. Data from
previous studies by KHRC and from a national prevalence survey, both indicate a VAD problem
of public health significance in the area -- 26% of breastmilk samples have retinol
concentrations lower than 30µg/dl, exceeding the WHO cut-off of 25% for defining areas with a
severe problem (WHO, 1996). VAS has been found to substantially reduce childhood morbidity
and mortality in similar areas, thus it is suitable for testing the potential benefits of VAS
to women.
All women aged 15-45 years who are permanent residents in the study areas will be eligible
for recruitment into the trial. They will be identified from existing databases. Permanent
residence is defined as having been resident in the area for the three months preceding the
start of recruitment, with intention to remain in the study area for the following 12 months.
There will be no exclusions to participation, except for women who have nightblindness or
other signs of VAD. These, and any women who develop VAD in the course of the study will be
treated according to current IVACG recommendations (IVACG, 1997). They will continue to be
followed, but will be given vitamin A and considered separately in the analysis. Continuous
recruitment will be done for women who migrate into the study area, or those who become
eligible by age as the study progresses. Allocation to treatment will be determined by the
cluster of residence.
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