Non-inferiority of Lower Dose Calcium Supplementation During Pregnancy

Pregnancy Related Clinical Trial

Official title:

Demonstrating Non-inferiority of Lower Dose Calcium Supplementation During Pregnancy for Reducing Preeclampsia and Neonatal Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03350516
• Other study ID #: OPP1172660
• Status: Completed
• Phase: Phase 3
• Start date: November 30, 2018
• Est. completion date: December 16, 2022

Study information

• Verified date: October 2023
• Source: Harvard School of Public Health (HSPH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22000
• Est. completion date: December 16, 2022
• Est. primary completion date: November 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Dietary Supplement:
• Daily 500 mg elemental calcium as calcium carbonate
Pregnant women in this arm will be provided and counselled to take three tablets, one containing 500 mg elemental calcium as calcium carbonate and 2 placebo supplements daily (total of 500 mg daily). The supplements in India will also contain 83.3 IU each of vitamin D3, for a total of 250 IU daily. No vitamin D3 will be given in Tanzania.
• Daily1500 mg elemental calcium as calcium carbonate
Pregnant women in this arm will be provided and counselled to take three tablets each containing 500 mg elemental calcium as calcium carbonate daily (total of 1500 mg daily) as currently recommended by the World Health Organization. The supplements in India will also contain 83.3 IU each of vitamin D3, for a total of 250 IU daily. No vitamin D3 will be given in Tanzania.

Locations

Country	Name	City	State
India	St. John's Research Institute	Bangalore
Tanzania	Africa Academy for Public Health	Dar Es Salaam
Tanzania	Ifakara Health Institute	Dar Es Salaam

Sponsors (4)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)	Africa Academy for Public Health, Ifakara Health Institute, St. John's Research Institute

Countries where clinical trial is conducted

India,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of pregnant women with incident preeclampsia		Gestational week 20 to Delivery
Primary	Proportion of preterm birth		Birth