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ISRCTN
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ISRCTN13994081
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ClinicalTrials.gov identifier
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Public title
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Effect of tempe and vitamin C rich fruit supplementation during pregnancy on iron status and pregnancy outcomes
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Does food-based intervention using tempe and vitamin C rich fruit during pregnancy improve the iron status?
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Ethics approval
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Ethical Committee for Studies on Human Subjects, Faculty of Medicine, University of Indonesia. Date of approval: 19/02/2007 (ref: 49/PTO2.FK/ETIK/2007)
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Study design
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Randomised controlled single-centre trial (unit of randomisation: village).
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Countries of recruitment
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Indonesia
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Disease/condition/study domain
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Anaemia during pregnancy
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Participants - inclusion criteria
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1. Pregnant women, gestation 12-20 weeks
2. Age 15-49 years
3. No existing severe maternal illness
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Participants - exclusion criteria
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1. Suffer from chronic disease
2. In medication/antibiotic treatment
3. Do not sign inform consent
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Anticipated start date
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01/11/2007
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Anticipated end date
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01/11/2008
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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250
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Interventions
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The participating villages will be randomly allocated to the following two groups:
Supplementary group will receive supplementary food, 400 mg albendazole, and health and nutrition
education. The average weekly supplementary food consist of: 600 g tempe (fermented soybean), 30 g red meat/dried anchovy/chicken liver, 45 g soy sauce, 350 g guava, 300 g papaya and 100 g orange. Supplementary food will be given daily at 12-20 week of gestation until delivery at home.
Control group will receive 400 mg albendazole only.
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Primary outcome measure(s)
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Maternal iron status at gestation 12-20 week:
1. Haemoglobin
2. Ferritin
3. Soluble transferrin receptors
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Secondary outcome measure(s)
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1. Infectious status at gestation 12-20 weeks and 32-36 weeks:
1.1. C-reactive protein
1.2. A-1 acid glycoprotein
2. Helminth infestation (hookworms, A.lumbricoides, T.trichiura) measured quantitatively (eggs per gram) at gestation 12-20 weeks and 32-36 weeks
3. Gestational age calculated from date of last menstruation and palpation
4. Weight gain of pregnant women and birth weight of infant will be measured with electronic weighing scale
5. Length of infant will be measured with length board
6. Complication deliveries/fetal loss will be measured with verbal autopsy interviews, less than 3 days after delivery
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Sources of funding
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Nestle Foundation (Switzerland)
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Trial website
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Publications
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Contact name
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Mrs
Maria
Wijaya-Erhardt
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Address
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Seameo-Tropmed RCCN-UI
Jl. Salemba Raya 6
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City/town
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Jakarta
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Zip/Postcode
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10430
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Country
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Indonesia
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Tel
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+62 21 3914017
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Fax
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+62 21 3914017
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Email
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mwijaya@seameo-rccn.org
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Sponsor
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Nestle Foundation (Switzerland)
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Address
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4, Place de la Gare
PO BOX 581
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City/town
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Lausanne
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Zip/Postcode
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1001
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Country
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Switzerland
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Tel
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+41 21 320 33 51
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Fax
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+41 21 320 33 92
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Email
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nf@nestlefoundation.org
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Sponsor website:
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http://www.nestlefoundation.org
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Date applied
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06/09/2007
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Last edited
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08/04/2008
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Date ISRCTN assigned
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08/04/2008
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