Non-inferiority of Lower Dose Calcium Supplementation During Pregnancy

Status Completed

Clinical Trial 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 preferably taken at mealtimes, in addition to daily iron folic-acid supplements. Despite proven efficacy and the WHO recommendation, calcium supplementation in pregnancy is not standard of care in the vast majority of low-income and middle-income countries. Two important barriers to implementation are the cost of the supplements and complexity of the suggested calcium dosing schedule. A lower dose of calcium (500 mg) administered as a single dose has been shown to be beneficial in several trials, and if found to be as effective as the 1500 mg supplementation regimen, it may help overcome these barriers and increase individual and health system adoption. The Investigators will conduct two parallel, individually randomized, double blind non-inferiority trials in India and Tanzania. Participating pregnant woman will be randomized to either 1500 mg or 500 mg calcium supplementation. The India and Tanzania trials are independently powered for the primary outcomes of i) preeclampsia and ii) preterm birth. The India and Tanzania sites will each enroll 11,000 participants.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Pregnancy Related

Clinical Trial Details

NCT number	NCT03350516
Study type	Interventional
Source	Harvard School of Public Health (HSPH)
Contact
Status	Completed
Phase	Phase 3
Start date	November 30, 2018
Completion date	December 16, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05017974` - Research on Improving Sleep During Pregnancy	N/A
Completed	`NCT03284515` - Vaccination In Pregnancy Gene Signature: VIP Signature Study
Recruiting	`NCT05969795` - Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support	Phase 1
Recruiting	`NCT06051201` - Innovation for Small-scale Experiments: ReceptIVFity Test	N/A
Recruiting	`NCT04828382` - Prospective Study of Pregnancy in Women With Cystic Fibrosis
Enrolling by invitation	`NCT04527926` - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy	N/A
Recruiting	`NCT04278651` - Early Antenatal Support for Iron Deficiency Anemia	Phase 4
Recruiting	`NCT04405700` - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting	`NCT06258902` - Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Completed	`NCT05487196` - Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia	Phase 2
Completed	`NCT03750968` - Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects	Phase 2
Enrolling by invitation	`NCT06127277` - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care	N/A
Completed	`NCT05897697` - Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
Recruiting	`NCT05899101` - The Impact of Opioid and Cannabis Exposure on Fetal Growth
Completed	`NCT05502510` - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Completed	`NCT04296396` - Opioid Prescription After Cesarean Trial	Phase 3
Not yet recruiting	`NCT06069856` - Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial	Phase 3
Not yet recruiting	`NCT06069869` - Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial	Phase 3
Not yet recruiting	`NCT06079918` - Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania	Phase 3
Not yet recruiting	`NCT04960800` - Effect of a Specific Exercise Program During Pregnancy on Diastasis Recti Abdominis	N/A