Condition category
Pregnancy and Childbirth
Date applied
19/03/2004
Date assigned
01/04/2004
Last edited
25/08/2011
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

Dr José Villar

ORCID ID

Contact details

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
villarj@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/HRP ID 98295

Study information

Scientific title

Acronym

Study hypothesis

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

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

Study design

Multicentre double blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Calcium supplementation

Primary outcome measures

1. Primary maternal outcome: incidence of preeclampsia and/or eclampsia
2. Primary neonatal outcome: preterm delivery

Secondary outcome measures

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

Overall trial start date

01/11/2001

Overall trial end date

01/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Nulliparous pregnant women less than 20 weeks gestation
2. Living in low calcium intake areas

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

8500

Participant 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

Recruitment start date

01/11/2001

Recruitment end date

01/06/2003

Locations

Countries of recruitment

Argentina, Egypt, India, Peru, South Africa, Viet Nam

Trial participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction

Sponsor details

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

Sponsor type

Research organisation

Website

http://www.who.int/reproductive-health/hrp/

Funders

Funder type

Research organisation

Funder name

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)

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

Results in:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16522392

Publication citations

  1. Results

    Villar J, Abdel-Aleem H, Merialdi M, Mathai M, Ali MM, Zavaleta N, Purwar M, Hofmeyr J, Nguyen TN, Campódonico L, Landoulsi S, Carroli G, Lindheimer M, , World Health Organization randomized trial of calcium supplementation among low calcium intake pregnant women., Am. J. Obstet. Gynecol., 2006, 194, 3, 639-649, doi: 10.1016/j.ajog.2006.01.068.

Additional files

Editorial Notes