Calcium supplementation during pregnancy in low-intake populations

ISRCTN	ISRCTN37214165
DOI	https://doi.org/10.1186/ISRCTN37214165
Protocol serial number	WHO/HRP ID 98295
Sponsor	UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Funder	United Nations Development Programme (UNDP)/United Nations Population Fund (UNFPA)/World Health Organization (WHO)/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)

Submission date: 19/03/2004
Registration date: 01/04/2004
Last edited: 10/11/2022

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

Dr José Villar
Scientific

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Email	villarj@who.int

Study information

Primary study design	Interventional
Study design	Multicentre double blind randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Calcium supplementation during pregnancy in low-intake populations
Study objectives	The purpose of this trial was to determine whether calcium supplementation of pregnant women with low calcium intake reduces pre-eclampsia and preterm delivery.
Ethics approval(s)	This trial was approved by: 1. The Scientific and Ethical Review Group at UNDP/UNFPA/WHO/World Bank Special Programme for Research, Development and Research Training in Human Reproduction 2. The WHO Secretariat Committee for Research into Human Subjects 3. The Institutional Review Boards of participating centres
Health condition(s) or problem(s) studied	Pre-eclampsia
Intervention	Women were assigned randomly to receive: 1. Calcium-containing tablets (1.5 g/d), one tablet three times daily (at meal time, greater than 3 hours after any iron supplements) 2. Indentical placebo Treatment continued from enrolment to delivery. Treatment was discontinued when magnesium sulphate therapy was initiated to treat pre-eclampsia or when nephrolithiasis was diagnosed, but not when pre-eclampsia or hypertension was diagnosed.
Intervention type	Supplement
Primary outcome measure(s)	1. Primary maternal outcome: incidence of preeclampsia and/or eclampsia 2. Primary neonatal outcome: preterm delivery
Key secondary outcome measure(s)	1. Early preterm delivery (less than 32 weeks of gestation) 2. Term low birth weight (less than 2500 g; greater than or equal to 37 weeks of gestation) 3. Hospitalisation of greater than 2 days 4. Greater than or equal to 7 days in the neonatal intensive care unit 5. Foetal, neonatal, and perinatal death
Completion date	01/06/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	8500
Total final enrolment	8325
Key inclusion criteria	1. Nulliparous pregnant women less than 20 weeks gestation 2. Living in low calcium intake areas
Key exclusion criteria	1. The presence of blood pressure greater than 140 and/or 90 mmHg at first antenatal visit 2. A history of chronic hypertension or renal disease 3. A history or signs and/or symptoms of nephrolithiasis, parathyroid disorders, and diseases that require digoxin, phenytoin, or tetracycline therapy
Date of first enrolment	01/11/2001
Date of final enrolment	01/06/2003

Locations

Countries of recruitment

Argentina
Egypt
India
Peru
South Africa
Switzerland
Viet Nam

Study participating centre

World Health Organization

Geneva-27
CH-1211
Switzerland

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/03/2006		Yes	No

Editorial Notes

10/11/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.