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Non-inferiority of Lower Dose Calcium Supplementation During Pregnancy

NCT ID: NCT03350516

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

22000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2022-12-16

Brief Summary

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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

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Conditions

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Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Daily 500 mg Calcium

Group Type EXPERIMENTAL

Daily 500 mg elemental calcium as calcium carbonate

Intervention Type DIETARY_SUPPLEMENT

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 Calcium (Standard dose)

Group Type ACTIVE_COMPARATOR

Daily1500 mg elemental calcium as calcium carbonate

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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St. John's Research Institute

OTHER

Sponsor Role collaborator

Ifakara Health Institute

OTHER

Sponsor Role collaborator

Africa Academy for Public Health

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

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Wafaie Fawzi

Richard Saltonstall Professor of Population Sciences, Professor of Nutrition, Epidemiology, and Global Health, Chair of the Department of Global Health and Population

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wafaie W Fawzi, MBBS, DrPH

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Locations

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St. John's Research Institute

Bangalore, , India

Site Status

Africa Academy for Public Health

Dar es Salaam, , Tanzania

Site Status

Ifakara Health Institute

Dar es Salaam, , Tanzania

Site Status

Countries

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India Tanzania

References

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Dwarkanath P, Muhihi A, Sudfeld CR, Wylie BJ, Wang M, Perumal N, Thomas T, Kinyogoli SM, Bakari M, Fernandez R, Raj JM, Swai NO, Buggi N, Shobha R, Sando MM, Duggan CP, Masanja HM, Kurpad AV, Pembe AB, Fawzi WW. Two Randomized Trials of Low-Dose Calcium Supplementation in Pregnancy. N Engl J Med. 2024 Jan 11;390(2):143-153. doi: 10.1056/NEJMoa2307212.

Reference Type RESULT
PMID: 38197817 (View on PubMed)

Pembe AB, Dwarkanath P, Kikula A, Raj JM, Perumal N, Paulo HA, M R, Duggan CP, Masanja HM, Chopra N, Sando MM, Thomas T, Yelverton CA, Muhihi A, Kurpad AV, Fawzi WW, Wylie BJ, Sudfeld CR. Hypertensive disorders of pregnancy and perinatal outcomes: two prospective cohort studies of nulliparous women in India and Tanzania. BMJ Glob Health. 2025 Jul 10;10(7):e016339. doi: 10.1136/bmjgh-2024-016339.

Reference Type DERIVED
PMID: 40639854 (View on PubMed)

Dwarkanath P, Muhihi A, Sudfeld CR, Rani S, Duggan CP, Sando MM, Wylie BJ, Fernandez R, Kinyogoli S, Munk C, Perumal N, Raj JM, Buggi N, Swai N, Thomas T, Wang M, Kurpad AV, Masanja H, Pembe AB, Fawzi WW. Non-inferiority of low-dose compared to standard high-dose calcium supplementation in pregnancy: study protocol for two randomized, parallel group, non-inferiority trials in India and Tanzania. Trials. 2021 Nov 24;22(1):838. doi: 10.1186/s13063-021-05811-7.

Reference Type DERIVED
PMID: 34819147 (View on PubMed)

Other Identifiers

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OPP1172660

Identifier Type: -

Identifier Source: org_study_id