Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120822
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-07-12
Brief Title:
Folic Acid Supplementation in Gambian Primigravidae
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
A Study of the Effect of Folic Acid Supplementation on the Anti-malarial Action of Sulfadoxine-pyrimethamine When Used for Intermittent Preventive Treatment in Gambian Primigravidae
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Supplementation with folic acid and iron is recommended for pregnant women in order to prevent them from developing anemia In malaria endemic areas of Africa the World Health Organization WHO now recommends that pregnant women should also be given sulfadoxine-pyrimethamine SP once a month after quickening to protect them against malaria which is especially harmful during pregnancy However folic acid is an antagonist of SP so there is a possibility that giving folic acid with SP could interfere with the ability of the latter to provide protection against malaria To investigate this possibility Gambian primigravidae with malaria parasitemia have been given SP and folic acid at the same time or on separate occasions two weeks apart and the ability of SP to cure the malaria infection investigated
Detailed Description:
Objective
The objective of this study is to determine if administration of folic acid to pregnant women at the same time as sulfadoxine-pyrimethamine SP is given to prevent malaria interferes with the protective effect of the SP
Study area
The study was carried out in 14 mother and child health MCH clinics situated on the north and south banks of the River Gambia near to the town of Farafenni in the centre of the country In this area malaria is highly seasonal with an entomological inoculation rate of 10-50 infectious bites per year
Study population
Primigravidae who attended one of the study clinics were reviewed to assess their eligibility to join the study Entry criteria were - pregnancy 15 weeks haemoglobin Hb 7gdl absence of any underlying serious disease absence of a history of an adverse reaction to sulfonamide residence in the study area and a willingness to be visited at home
Study procedure
Eligible women were asked if they wished to join the trial and if so written informed consent was obtained An entry questionnaire was then completed and a finger-prick blood sample obtained for determination of Hb and preparation of two thick blood films Provided the woman had a Hb 7gdl she was then given a study number and formally entered into the trial Women were then individually randomised to receive SP and iron folic acid early folate group or SP and iron late folate group
All women in the trial received three tablets of SP 25 mg pyrimethamine and 500 mg sulfadoxine Cosmos Pharmaceutical Nairobi given under observation Women in the early folic acid group then received a packet containing Fefol 500 ug of folic acid and 47 mg of ferrous sulfate to be taken at home once per day for 14 days Women in the late folic acid group received packets containing oral iron 60 mgday alone to be taken daily for 14 days At the day 14 follow-up they then received iron and folic acid so no woman was deprived of folic acid supplementation
At the end of the 14 day period women were visited at home and a repeat finger-prick blood sample obtained for determination of Hb and preparation of two thick blood films
Haemoglobin was measured using a Haemocue and blood films were examined for malaria parasites after staining with Giemsa by two microscopists blind to the treatment code If discrepant results were found a third reading was done and the majority view accepted
Trial end-point
The primary end-point for the trial was the prevalence of Plasmodium falciparum asexual parasitemia 14 days after treatment in women who were parasitemic on presentation Parasite prevalence at day 14 irrespective of initial findings and mean Hb at day 14 were secondary end-points
Sample size
It was assumed that 30 of women would be parasitemic on presentation and that the cure rate with SP in those who did not receive folic acid at the same time would be 97 To have 90 power at the 5 level of significance to show a 10 reduction in the cure rate with SP when this is given with folic acid 483 women were required for each arm of the trial
Data Safety Monitoring Board DSMB
A DSMB was established to monitor the conduct of the trial and to approve the analytical plan prior to the breaking of the study code The trial was conducted in line with the requirements of Good Clinical Practice
The objective of this study is to determine if administration of folic acid to pregnant women at the same time as sulfadoxine-pyrimethamine SP is given to prevent malaria interferes with the protective effect of the SP
Study area
The study was carried out in 14 mother and child health MCH clinics situated on the north and south banks of the River Gambia near to the town of Farafenni in the centre of the country In this area malaria is highly seasonal with an entomological inoculation rate of 10-50 infectious bites per year
Study population
Primigravidae who attended one of the study clinics were reviewed to assess their eligibility to join the study Entry criteria were - pregnancy 15 weeks haemoglobin Hb 7gdl absence of any underlying serious disease absence of a history of an adverse reaction to sulfonamide residence in the study area and a willingness to be visited at home
Study procedure
Eligible women were asked if they wished to join the trial and if so written informed consent was obtained An entry questionnaire was then completed and a finger-prick blood sample obtained for determination of Hb and preparation of two thick blood films Provided the woman had a Hb 7gdl she was then given a study number and formally entered into the trial Women were then individually randomised to receive SP and iron folic acid early folate group or SP and iron late folate group
All women in the trial received three tablets of SP 25 mg pyrimethamine and 500 mg sulfadoxine Cosmos Pharmaceutical Nairobi given under observation Women in the early folic acid group then received a packet containing Fefol 500 ug of folic acid and 47 mg of ferrous sulfate to be taken at home once per day for 14 days Women in the late folic acid group received packets containing oral iron 60 mgday alone to be taken daily for 14 days At the day 14 follow-up they then received iron and folic acid so no woman was deprived of folic acid supplementation
At the end of the 14 day period women were visited at home and a repeat finger-prick blood sample obtained for determination of Hb and preparation of two thick blood films
Haemoglobin was measured using a Haemocue and blood films were examined for malaria parasites after staining with Giemsa by two microscopists blind to the treatment code If discrepant results were found a third reading was done and the majority view accepted
Trial end-point
The primary end-point for the trial was the prevalence of Plasmodium falciparum asexual parasitemia 14 days after treatment in women who were parasitemic on presentation Parasite prevalence at day 14 irrespective of initial findings and mean Hb at day 14 were secondary end-points
Sample size
It was assumed that 30 of women would be parasitemic on presentation and that the cure rate with SP in those who did not receive folic acid at the same time would be 97 To have 90 power at the 5 level of significance to show a 10 reduction in the cure rate with SP when this is given with folic acid 483 women were required for each arm of the trial
Data Safety Monitoring Board DSMB
A DSMB was established to monitor the conduct of the trial and to approve the analytical plan prior to the breaking of the study code The trial was conducted in line with the requirements of Good Clinical Practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None