Welcome
Support Centre
25 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Impact of iron/folate versus multi-micronutrient supplementation during pregnancy on birth weight: a randomised controlled trial in rural Western China
ISRCTN ISRCTN08850194
DOI 10.1186/ISRCTN08850194
ClinicalTrials.gov identifier
EudraCT number
Public title Impact of iron/folate versus multi-micronutrient supplementation during pregnancy on birth weight: a randomised controlled trial in rural Western China
Scientific title
Acronym N/A
Serial number at source YH101-H12/03
Study hypothesis 1. The newborn infants of women receiving the multi-micronutrient supplements will at least experience a 50% reduction in prevalence of low birth weight (less than 2500 g) in comparison those receiving folate alone.
2. The newborn infants of women receiving the iron/folate supplements will at least experience a 25% reduction in the prevalence of low birth weight (less than 2500 g) in comparison those receiving folate alone
3. The women receiving the multi-micronutrient supplements in comparison those receiving iron/folate supplements, will at least experience a 30% reduction in the prevalence of anemia (Haemoglobin [Hb] less than 11 g/dL) in the third trimester (30 to 32 weeks of gestation).
Lay summary Not provided at time of registration
Ethics approval The study was approved by the Committee for Science and Research at the Xi’an Jiaotong University on April 10, 2002 (reference number: 2002002).
Study design Grouped randomised double-blind controlled community trial
Countries of recruitment China
Disease/condition/study domain Low birth weight; preterm delivery; anaemia
Participants - inclusion criteria Women invited to participate in the trial must be less than 28 weeks of gestation
Participants - exclusion criteria Women will be excluded from the trial if already taking iron, folate, and other micronutrients supplements for more than two weeks
Anticipated start date 01/08/2002
Anticipated end date 24/01/2006
Status of trial Completed
Patient information material
Target number of participants 7144 eligible pregnant women
Interventions Hamlets were randomly assigned for women to receive one of the following three daily antenatal supplements:
1. Multi-micronutrients
2. Iron and folic acid
3. Folic acid alone (control)

The multi-micronutrient supplements were formuated to contain the Required Dietary Allowances (RDA) for each of the micronutrients and if taken throughout pregnancy should provide a sufficient intake of each micronutrient to correct any underlying deficiencies (30 mg iron, 400 µg folate, 15.0 mg zinc, 2.0 mg copper, 65.0 µg selenium, 150.0 µg iodine, 800.0 µg vitamin A, 1.4 mg Vitamin B1, 1.4 mg vitamin B2, 1.9 mg vitamin B6, 2.6 µg vitamin B12, 5.0 µg vitamin D, 70.0 mg vitamin C, 10.0 mg vitamin E, and 18.0 mg Niacin). The iron/folate supplements contained 60 mg of iron and 400 µg of folic acid. The folate-only supplement contained 400 µg of folic acid.

These supplements were identical in appearance and participants, investigators, field staff, and statisticians did nor know supplement codes until the study finished.
Primary outcome measure(s) 1. Duration of pregnancy
2. Birth weight, length and head circumference
3. Haemoglobin level of pregnant women at the start of their third trimester
Secondary outcome measure(s) 1. Compliance with supplements
2. Side effects of supplements
3. Complications of pregnancy:
3.1. Hypertension and preeclampsia
3.2. Antepartum haemorrhage
3.3. Infections
4. Type of delivery and type of assistance
5. Delivery complications:
5.1. Prolonged labour
5.2. Postpartum haemorrhage
5.3. Duration of maternal hospital admission
6. Early neonatal morbidity
Sources of funding United Nations Children's Fund (UNICEF) (China) (Project No.: YH101-H12/03)
Trial website
Publications 1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18996930
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19589154
3. 2012 30 month follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/22085869
Contact name Prof  Hong  Yan
  Address No 76 Western Yanta Road
  City/town Xi'an
  Zip/Postcode 710061
  Country China
  Tel +86 (0)29 8265 5001
  Fax +86 (0)29 8265 5387
  Email yanhonge@mail.xjtu.edu.cn
Sponsor United Nations Children's Fund (UNICEF) (China)
  Address c/o Lilian Selenje
Health and Nutrition
12 Sanlitun Lu
  City/town Beijing
  Zip/Postcode 100600
  Country China
  Sponsor website: http://www.unicef.org/china/index.html
Date applied 17/11/2006
Last edited 20/06/2012
Date ISRCTN assigned 14/12/2006
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.