Calcium supplementation during pregnancy in low-intake populations
| ISRCTN | ISRCTN37214165 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37214165 |
| Secondary identifying numbers | WHO/HRP ID 98295 |
- 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
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| villarj@who.int |
Study information
| Study design | Multicentre double blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/11/2001 |
| Completion date | 01/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
CH-1211
Switzerland
Sponsor information
UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Research organisation
Research organisation
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Website | http://www.who.int/reproductive-health/hrp/ |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
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)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
