Impact of iron/folate versus multi-micronutrient supplementation during pregnancy on birth weight: a randomised controlled trial in rural Western China

ISRCTN	ISRCTN08850194
DOI	https://doi.org/10.1186/ISRCTN08850194
Protocol serial number	YH101-H12/03
Sponsor	United Nations Children's Fund (UNICEF) (China)
Funder	UNICEF (Project No.: YH101-H12/03)

Submission date: 17/11/2006
Registration date: 14/12/2006
Last edited: 19/12/2022

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Hong Yan
Scientific

No 76 Western Yanta Road
Xi'an
710061
China

Phone	+86 (0)29 8265 5001
Email	yanhonge@mail.xjtu.edu.cn

Study information

Primary study design	Interventional
Study design	Grouped randomised double-blind controlled community trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Impact of iron/folate versus multi-micronutrient supplementation during pregnancy on birth weight: a randomised controlled trial in rural Western China
Study objectives	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).
Ethics approval(s)	Committee for Science and Research at the Xi'an Jiaotong University, 10/04/2002, ref: 2002002
Health condition(s) or problem(s) studied	Low birth weight; preterm delivery; anaemia
Intervention	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.
Intervention type	Supplement
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
Key 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
Completion date	24/01/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	7144
Total final enrolment	5828
Key inclusion criteria	Women invited to participate in the trial must be less than 28 weeks of gestation
Key exclusion criteria	Women will be excluded from the trial if already taking iron, folate, and other micronutrients supplements for more than two weeks
Date of first enrolment	01/08/2002
Date of final enrolment	24/01/2006

Locations

Countries of recruitment

China

Study participating centre

No 76 Western Yanta Road

Xi'an
710061
China

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	07/11/2008		Yes	No
Results article	results	09/07/2009		Yes	No
Results article	30-month follow-up results	01/02/2012		Yes	No
Results article	results	01/08/2015		Yes	No
Results article	results	01/11/2016		Yes	No
Results article	results	01/09/2018		Yes	No
Results article	results	01/06/2020	12/08/2019	Yes	No
Results article	14-year follow-up	07/12/2022	19/12/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

19/12/2022: Publication reference added.
12/08/2019: Publication reference and total final enrolment added.
11/07/2018: Publication reference added.
28/07/2016: Publication reference added.