Effect of tempe and vitamin C rich fruit supplementation during pregnancy on iron status and pregnancy outcomes

ISRCTN	ISRCTN13994081
DOI	https://doi.org/10.1186/ISRCTN13994081
Protocol serial number	N/A
Sponsor	Nestle Foundation (Switzerland)
Funder	Nestle Foundation (Switzerland)

Submission date: 06/09/2007
Registration date: 08/04/2008
Last edited: 08/04/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Maria Wijaya-Erhardt
Scientific

Seameo-Tropmed RCCN-UI
Jl. Salemba Raya 6
Jakarta
10430
Indonesia

Phone	+62 21 3914017
Email	mwijaya@seameo-rccn.org

Study information

Primary study design	Interventional
Study design	Randomised controlled single-centre trial (unit of randomisation: village).
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Does food-based intervention using tempe and vitamin C rich fruit during pregnancy improve the iron status?
Ethics approval(s)	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)
Health condition(s) or problem(s) studied	Anaemia during pregnancy
Intervention	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.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Tempe and albendazole
Primary outcome measure(s)	Maternal iron status at gestation 12-20 week: 1. Haemoglobin 2. Ferritin 3. Soluble transferrin receptors
Key secondary outcome measure(s)	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
Completion date	01/11/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	250
Key inclusion criteria	1. Pregnant women, gestation 12-20 weeks 2. Age 15-49 years 3. No existing severe maternal illness
Key exclusion criteria	1. Suffer from chronic disease 2. In medication/antibiotic treatment 3. Do not sign inform consent
Date of first enrolment	01/11/2007
Date of final enrolment	01/11/2008

Locations

Countries of recruitment

Indonesia

Study participating centre

Seameo-Tropmed RCCN-UI

Jakarta
10430
Indonesia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan