Non-inferiority of Lower Dose Calcium Supplementation During Pregnancy

Phase 3

Completed

• Conditions: Pregnancy Related
• Interventions: Dietary Supplement: Daily1500 mg elemental calcium as calcium carbonate; Dietary Supplement: Daily 500 mg elemental calcium as calcium carbonate

• Registration Number: NCT03350516
• Lead Sponsor: Harvard School of Public Health (HSPH)

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-19
• Study First Submitted QC: 2017-11-19
• Study First Posted: 2017-11-22
• Study Start: 2018-11-30
• Primary Completion: 2022-11-03
• Study Completion: 2022-12-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily1500 mg Calcium (Standard dose)	Daily1500 mg elemental calcium as calcium carbonate	-
Daily 500 mg Calcium	Daily 500 mg elemental calcium as calcium carbonate	-

Primary Outcome Measures

Name	Time	Method
Proportion of preterm birth	Birth
Proportion of pregnant women with incident preeclampsia	Gestational week 20 to Delivery

Trial Locations

Locations (3)

Africa Academy for Public Health; 🇹🇿 Dar Es Salaam, Tanzania

St. John's Research Institute; 🇮🇳 Bangalore, India

Ifakara Health Institute; 🇹🇿 Dar Es Salaam, Tanzania