Status:
COMPLETED
Effect of Maternal Vitamin D3 Supplementation on Iron Status During Pregnancy and Early Infancy
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
International Centre for Diarrhoeal Disease Research, Bangladesh
Bill and Melinda Gates Foundation
Conditions:
Pregnancy
Eligibility:
FEMALE
18-100 years
Phase:
PHASE3
Brief Summary
This is a secondary-use study based on previously-collected data and blood samples from a previously completed double-blind, dose-ranging trial of maternal prenatal and postpartum vitamin D supplement...
Detailed Description
The risk of both low iron and vitamin D status have been recognized as public health concerns among pregnant women and young children, with high rates of deficiency in low-and middle-income countries....
Eligibility Criteria
Inclusion
- Women aged 18 years and above.
- Gestational age of 17 to 24 completed weeks estimated based on recalled last menstrual period (LMP) and/or ultrasound.
- Intends to permanently reside in the trial catchment area for at least 18 months
- MDIG trial participants with availability of at least one measurement of the biomarkers of interest (serum ferritin, circulating hepcidin, transferrin, soluble transferrin receptor, serum iron and/or whole-blood Hb).
Exclusion
- History of medical conditions that may predispose the participant to vitamin D sensitivity, altered vitamin D metabolism and/or hypercalcemia, or history of renal calculi.
- High-risk pregnancy based on one or more of the following findings by point-of-care testing:
- \- Severe anemia: hemoglobin \<70 g/L assessed by Hemocue.
- \- Moderate-severe proteinuria: ≥ 300 mg/dl (3+ or 4+) based on urine dipstick.
- \- Hypertension: systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg.
- \- Multiple gestation, major congenital anomaly, or severe oligohydramnios based on maternal history and/or ultrasound.
- \- Unwillingness to stop taking non-study vitamin D or calcium supplements or a multivitamin with calcium and/or vitamin D.
- \- Currently prescribed vitamin D supplements as part of a physician's treatment plan for vitamin D deficiency.
- \- Previous participation in the same study.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT04764955
Start Date
March 1 2014
End Date
March 1 2018
Last Update
June 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh