|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
23 October 2023 |
|
Main ID: |
NCT03350516 |
|
Date of registration:
|
19/11/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Non-inferiority of Lower Dose Calcium Supplementation During Pregnancy
|
|
Scientific title:
|
Demonstrating Non-inferiority of Lower Dose Calcium Supplementation During Pregnancy for Reducing Preeclampsia and Neonatal Outcomes |
|
Date of first enrolment:
|
November 30, 2018 |
|
Target sample size:
|
22000 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT03350516 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
India
|
Tanzania
| | | | | | |
|
Contacts
|
|
Name:
|
Wafaie W Fawzi, MBBS, DrPH |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Harvard School of Public Health (HSPH) |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Nulliparous
- Attending first ANC visit at study clinics
- Pregnant women <20 weeks
- = 18 years old
- Intending to stay in study area until 6 weeks post delivery
- Provides informed consent
Exclusion Criteria:
- History or signs and/or symptoms of nephrolithiasis
- Prior diagnosis of parathyroid disorder or thyroidectomy
- Diseases that require digoxin, phenytoin, or tetracycline therapy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Pregnancy Related
|
|
Intervention(s)
|
|
Dietary Supplement: Daily 500 mg elemental calcium as calcium carbonate
|
|
Dietary Supplement: Daily1500 mg elemental calcium as calcium carbonate
|
|
Primary Outcome(s)
|
|
Proportion of pregnant women with incident preeclampsia
[Time Frame: Gestational week 20 to Delivery]
|
|
Proportion of preterm birth
[Time Frame: Birth]
|
|
Secondary ID(s)
|
|
OPP1172660
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|