Condition category
Pregnancy and Childbirth
Date applied
06/09/2007
Date assigned
08/04/2008
Last edited
08/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Maria Wijaya-Erhardt

ORCID ID

Contact details

Seameo-Tropmed RCCN-UI
Jl. Salemba Raya 6
Jakarta
10430
Indonesia
+62 21 3914017
mwijaya@seameo-rccn.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Does food-based intervention using tempe and vitamin C rich fruit during pregnancy improve the iron status?

Ethics approval

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)

Study design

Randomised controlled single-centre trial (unit of randomisation: village).

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

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 names

Tempe and albendazole

Primary outcome measures

Maternal iron status at gestation 12-20 week:
1. Haemoglobin
2. Ferritin
3. Soluble transferrin receptors

Secondary outcome measures

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

Overall trial start date

01/11/2007

Overall trial end date

01/11/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant women, gestation 12-20 weeks
2. Age 15-49 years
3. No existing severe maternal illness

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

250

Participant exclusion criteria

1. Suffer from chronic disease
2. In medication/antibiotic treatment
3. Do not sign inform consent

Recruitment start date

01/11/2007

Recruitment end date

01/11/2008

Locations

Countries of recruitment

Indonesia

Trial participating centre

Seameo-Tropmed RCCN-UI
Jakarta
10430
Indonesia

Sponsor information

Organisation

Nestle Foundation (Switzerland)

Sponsor details

4
Place de la Gare
PO BOX 581
Lausanne
1001
Switzerland
+41 21 320 33 51
nf@nestlefoundation.org

Sponsor type

Industry

Website

http://www.nestlefoundation.org

Funders

Funder type

Industry

Funder name

Nestle Foundation (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes