What is obaapaVita?

The ObaapaVitA trial is a cluster-randomised double-blind placebo-controlled trial to evaluate the impact of low-dose weekly Vitamin A Supplementation (VAS) to adult females on pregnancy-related mortality and all-cause mortality in rural Ghana.

The objectives of the trial are: to evaluate the impact of weekly VAS to women of reproductive age on maternal mortality and to compare this with the impact on overall mortality; to explore the possible causal pathways through which VAS might impact on maternal mortality; to evaluate the impact of weekly VAS to women, before and during pregnancy, on perinatal and infant mortality; and to contribute data to a future meta-analysis exploring whether any impact of VAS on pregnancy-related maternal mortality is restricted to specific causes. Women aged 15 to 45 years of age are randomised to receive 7,000 retinol equivalents of vitamin A or placebo each week, and are followed up for a range of mortality and morbidity endpoints. The results from the trial will be important not only in identifying the potential role of vitamin A in Safe Motherhood Initiatives, but also in providing an explanation for the mechanisms through which an impact on mortality may be mediated.

It is being conducted in six contiguous districts in the Brong Ahafo region in the centre of Ghana (Kintampo North, Kintampo South, Wenchi, Techiman, Nkoranza and Tain). The districts fall within the forest-savannah transitional ecological zone, and vitamin A rich foods are less available than in the forest regions in the south. Fieldwork began in Kintampo District in December 2000, in Wenchi (now includes Tain) in 2001, in Techiman in 2002 and in Nkoranza in January 2003.

Overview of field activities:
Fieldwork, which mainly takes the form of gathering data for ObaapaVitA, discussing participants concerns, the distribution of capsules and collection of unused capsules, usually takes place from Monday through to Thursday.

During this period all fieldworkers are resident within the communities participating in ObaapaVitA. The data forms completed by fieldworkers are then collected by supervisors during their routine and unscheduled field visits. The supervisors then pass the data forms on to the field office where they are collated to be forwarded to the central filing section located at KHRC, through their respective support offices. This activity takes place every Thursday of the week following data collection at all sites except at Kintampo, where it happens on the Monday of the following week. Once the forms are logged at the filing office, the data is entered electronically at the Computer Centre starting from the same day as they reach Kintampo.

Fieldworker meetings are held every Friday where field issues and other developments concerning the trial are discussed, and directives from the Trial Management Team (based at the KHRC) are communicated. Except under exceptional circumstances, there are no field activities over the weekends (with the exception of hospital supervisory work as noted below).

Hospital Data Capture:
Routine capture of data continued at the four hospitals in the four sites of the study. The data capture was not interrupted for any vacation. While new staff was recruited to fill the vacancies among hospital supervisors, all existing staff underwent retraining.

Summary of Activities for 2006

Meetings
A Trial Steering Committee (TSC) and Data Monitoring and Ethics Committee (DMEC) meet yearly to review the trial’s progress and, in the case of the DMEC, to carry out comparisons between the vitamin A and placebo groups with regards to baseline comparability and adverse outcomes. These two meetings for 2006 took place in March and June respectively. In order to accumulate sufficient births and maternal deaths to give the trial adequate power the DMEC has estimated that fieldwork will need to continue until September 2008, by which time approximately 90,000 completed pregnancies would have occurred. It is envisaged that the dissemination of results will occur in mid 2009.

Changes in Staff
A new acting Trial Director was appointed in February 2006. The overall turnover of staff conformed to the previously experienced rates, and did not adversely impact on the trial.