Impact of enriched food ration distribution to pregnant women in Maela refugee camp
Organizational Data
- DRKS-ID:
- DRKS00007736
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2015-02-27
- Last update in DRKS:
- 2015-02-27
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
In 2004, a change in the food ration is about to take place in refugee camps along the Thai-Burmese border; flour enriched in micronutrients and iron will be introduced and distributed to all camps’ inhabitants. The research question is whether the distribution of vitamins/iron supplemented food rations would have an impact on the nutritional status of pregnant and lactating women in Maela refugee camp (the largest of all refugee camps), and whether this supplementation would have an impact on fetal growth, pregnancy outcomes and infant growth and development. The objectives of the study are (1) To measure the changes in the hematological and iron status during pregnancy and breast-feeding (2) To measure the change in micronutrient status (vitamin A/E/B1 and zinc) among the same population of women (3) To measure the impact of the intervention on the fetal growth and pregnancy outcome (i.e. birthweight) (4) To study the impact of the vitamin changes in the occurrence of the delayed visual maturation (DVM) syndrome observed previously in this population and the potential role of pesticides (DDT) in its pathogenesis in a subgroup of women, and (5) To examine the impact by exposure to the pesticide (DDT) on fetal growth, pregnancy outcomes and infant development
Brief summary in scientific language
Since 1984, thousands of displaced people from neighbouring Burma have taken refuge in the North-western border of Thailand. The largest settlement is in Maela (pop 40,000). The displaced population receives medical assistance, food and basic supplies from humanitarian organizations. In 1990, vitamin B1 deficiency (Beriberi) was recognized as a major cause of infantile mortality in this population; all pregnant women received then a supplementary food ration. Infant mortality dropped considerably, but in 1995, 60% of pregnant women were still deficient in vitamins B1, 3-months after delivery. Apart from the consequences of vitamin B1 deficiency on infants’ survival, a unique syndrome of delayed visual maturation (DVM) was documented in over 90% of newborn. This neurological syndrome, for the first time described in a population, is most likely explained by a combination of micronutrients deficit, perhaps aggravated by the toxic effects of residual DDT. In addition, anaemia prevalence is high (30%) in the pregnant women population. A change in the food ration is about to take place: enriched flour will be introduced in July 2004 and distributed to all inhabitants of Maela camp. We propose to conduct a study to measure the impact of the supplementation in micronutrients and iron and the potential roles of pesticides on: • nutritional status of pregnant and breast-feeding women • pregnancy outcomes • prevalence of DVM syndrome • infant growth and development
Health condition or problem studied
- Free text:
- Nutritional status of pregnant and lactating women and role in fetal growth, pregnancy outcomes, infant growth and development
- Free text:
- Exposure to pesticides (DDT) and role in fetal growth, pregnancy outcomes, infant growth and development
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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.
Endpoints
- Primary outcome:
- 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:
- 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.
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
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- Thailand
- Number of study centers:
- Monocenter study
- Recruitment location(s):
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- Medical center Antenatal Care Clinic, Shoklo Malaria Research Unit; Maela refugee camp, Tak Province, Thailand
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2004-06-23
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2008-06-20
- Target Sample Size:
- 1080
- Final Sample Size:
- 1164
Inclusion Criteria
- Sex:
- Female
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- Additional 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%.
Addresses
Primary Sponsor
- Address:
- Oxford University, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine Research Building,Old Road Campus, Roosevelt Drive,OX3 7FZ, OxfordUnited Kingdom
- Telephone:
- +44 (0)1865 612900
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.tropicalmedicine.ox.ac.uk/home
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Shoklo Malaria Research Unit (SMRU)Prof. Francois Nosten,68/30, Bantung Rd.63110 TAK Mae SotThailand
- Telephone:
- +66 (0) 55 545 021
- Fax:
- +66 (0) 55 545 020
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.shoklo-unit.com/
Contact for Public Queries
- Address:
- Shoklo Malaria Research Unit,Dr. Verena Carrara,Mae SotThailand
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.shoklo-unit.com/
Principal Investigator
- Address:
- Shoklo Malaria Research Unit (SMRU)Prof. Francois Nosten,68/30, Bantung Rd.63110 TAK Mae SotThailand
- Telephone:
- +66 (0) 55 545 021
- Fax:
- +66 (0) 55 545 020
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.shoklo-unit.com/
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- Wellcome Trust,215 Euston Road,NW1 2BE London,United Kingdom
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.wellcome.ac.uk/funding/
Private sponsorship (foundations, study societies, etc.)
- Address:
- UBS Optimus Foundation,Augustinerhof 1,8098 Zürich,Switzerland
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ubs.com/optimusfoundation
Ethics Committee
Address Ethics Committee
- Address:
- Oxford Tropical Research Ethics Committee (OXTREC) - University of Oxford, [Oxford Tropical Research Ethics Committee (OXTREC)]Old Road (Block 60) - Churchill Hospital,OX3 7LJ Oxford,United Kingdom
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.tropicalmedicine.ox.ac.uk/oxtrec
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2004-05-15
- Ethics committee number:
- 009-04
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2004-06-22
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Publication: Micronutrient status in lactating mothers before and after introduction of micronutrient fortified flour
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry