Status:
COMPLETED
Non-inferiority of Lower Dose Calcium Supplementation During Pregnancy
Lead Sponsor:
Harvard School of Public Health (HSPH)
Collaborating Sponsors:
St. John's Research Institute
Ifakara Health Institute
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The World Health Organization currently recommends that pregnant women in populations with low calcium intake receive daily calcium supplementation (1500 - 2000 mg) divided into three doses which are ...
Eligibility Criteria
Inclusion
- 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
- History or signs and/or symptoms of nephrolithiasis
- Prior diagnosis of parathyroid disorder or thyroidectomy
- Diseases that require digoxin, phenytoin, or tetracycline therapy
Key Trial Info
Start Date :
November 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2022
Estimated Enrollment :
22000 Patients enrolled
Trial Details
Trial ID
NCT03350516
Start Date
November 30 2018
End Date
December 16 2022
Last Update
December 24 2024
Active Locations (3)
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1
St. John's Research Institute
Bangalore, India
2
Africa Academy for Public Health
Dar es Salaam, Tanzania
3
Ifakara Health Institute
Dar es Salaam, Tanzania