Impact of enriched food ration distribution to pregnant women in Maela refugee camp

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00007736
• Date of registration: 27/02/2015
• Prospective Registration: No
• Primary sponsor: Oxford University, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine Research Building,
• Public title: Impact of enriched food ration distribution to pregnant women in Maela refugee camp
• Scientific title: Impact of enriched food ration distribution to pregnant women in Maela refugee camp
• Date of first enrolment: 23/06/2004
• Target sample size: 1080
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00007736
• Study type: observational
• Study design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other

Countries of recruitment

Thailand

Contacts

• Name: Francois Nosten,
• Affiliation: Shoklo Malaria Research Unit (SMRU)

• Name: Verena Carrara,
• Affiliation: Shoklo Malaria Research Unit,

Key inclusion & exclusion criteria

Inclusion criteria: reproductive age group;
offspring of women enrolled in the observational study
Exclusion criteria: Pregnant women not having access to the refugee food ration.
Pregnant women or lactating mothers with a hematocrit below 20%.


Age minimum: None
Age maximum: None
Gender: Female

Health Condition(s) or Problem(s) studied

Nutritional status of pregnant and lactating women and role in fetal growth, pregnancy outcomes, infant growth and development Exposure to pesticides (DDT) and role in fetal growth, pregnancy outcomes, infant growth and development

Intervention(s)

Group 1: Observational study among pregnant and lactating women and their offspring: two sequential cross-sectional surveys to measure
(1) Micronutrient status (iron, zinc, vitamin A/E/B1) and DDT residues in blood (serum/whole blood) and breast milk in pregnant (1st, 2nd or 3rd trimester) and lactating women (week 12 post partum)
(2) Pregnancy outcomes by means of gestational age at outcome and newborn’s anthropometrics (birth weight, lenght, head circumference), and
(3) Prevalence of DVM and development delay/growth in infancy.

Primary Outcome(s)

Primary endpoint: Comparison of nutritional status of the mother (at each trimester of pregnancy) before and after the introduction of the enriched flour; hematocrit and micronutrient status in blood (iron, zinc, vitamin A/E/B1) were measured in two sequential cross-sectional studies - the first survey was conducted before and the second survey two years after the introduction of micronutrient fortified flour as a new food ration in the camp

Secondary Outcome(s)

Secondary endpoint 1: Comparison of nutritional status (prevalence of anaemia, vitamin deficiency and mean vitamin/micronutrient levels in blood and breast milk) in pregnancy and during breast feeding.

Secondary endpoint 2: Comparison of foetal growth and pregnancy outcome
(prevalence of low birth weight, small-for-gestation, premature, mean
anthropometric measurements) before and after the introduction of the enriched flour.

Secondary endpoint 3: Comparison of the DVM prevalence in children born to mothers who did not receive the flour and those who did and controlled for DDT exposure.

Secondary endpoint 4: Comparison of growth (i.e. prevalence of stunting, underweight) and cognitive development according to DDT exposure in utero.

Source(s) of Monetary Support

UBS Optimus Foundation,

Wellcome Trust,

Ethics review

Status: Approved
Approval date: 22/06/2004
Contact:

Oxford Tropical Research Ethics Committee (OXTREC) - University of Oxford, [Oxford Tropical Research Ethics Committee (OXTREC)]

Results

• Date Completed: 20/06/2008
• URL: http://drks.de/search/en/trial/DRKS00007736#studyResults