CTRI Number |
CTRI/2018/02/012119 [Registered on: 23/02/2018] Trial Registered Retrospectively |
Last Modified On: |
05/03/2018 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Nutraceutical |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Non-inferiority of Lower Dose Calcium Supplementation During Pregnancy |
Scientific Title of Study
Modification(s)
|
A cluster randomized trial to demonstrate the equivalency of lower dose calcium supplementation during pregnancy for reducing preeclampsia and preterm birth. |
Secondary IDs if Any
Modification(s)
|
Secondary ID |
Registry |
NCT03350516 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
Name |
Dr Anura V Kurpad |
Address |
St Johns National Academy of Health Sciences Sarjapura Road
Bangalore KARNATAKA 560034 India |
Phone |
910849466349 |
Fax |
|
Email |
a.kurpad@sjri.res.in |
|
Details Contact Person Scientific Query
Modification(s)
|
Name |
Dr Pratibha Dwarkanath |
Address |
St Johns National Academy of Health Sciences Sarjapura Road
Bangalore KARNATAKA 560034 India |
Phone |
910849466326 |
Fax |
|
Email |
pratibha@sjri.res.in |
|
Details Contact Person Public Query
Modification(s)
|
Name |
Dr Pratibha Dwarkanath |
Address |
St Johns National Academy of Health Sciences Sarjapura Road
Bangalore KARNATAKA 560034 India |
Phone |
910849466326 |
Fax |
|
Email |
pratibha@sjri.res.in |
|
Source of Monetary or Material Support
|
Bill and Melinda Gates Foundation, USA |
|
Primary Sponsor
|
Name |
Bill Melinda Gates Foundation USA |
Address |
Bill & Melinda Gates Foundation, P.O Box 23350, Seattle, WA 98102, US |
Type of Sponsor |
Other [Non-operating private foundation ] |
|
Details of Secondary Sponsor
|
Name |
Address |
Harvard TH Chan School of Public Health |
Harvard T.H Chan, School of Public Health, Boston, ma 02115, USA |
|
Countries of Recruitment
|
India United Republic of Tanzania |
Sites of Study
Modification(s)
|
No of Sites = 5 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Andreas Pembe |
Africa Academy for Public Health |
Plot #802, Mwai Kibaki Road, Mikocheni
P.O. Box 79810
Dar es Salaam, Tanzania. Not Applicable |
255227771623
andreapembe@yahoo.co.uk |
Dr Anura V Kurpad |
Banashankari Referral Hospital |
Banashankari Referral Hospital,17th Main 27th Cross BsK 2nd Stage Bangalore |
08049466349
a.kurpad@sjri.res.in |
Dr Anura V Kurpad |
H. Siddaiah Road Hospital |
Next to Lions Eye Hospital, Off J. C. Road, H. Siddaiah Road Bangalore |
08049466349
a.kurpad@sjri.res.in |
Honorati Masanja |
Ifakara Health Institute |
Plot 463, Kiko Avenue Mikocheni
Dar es Salaam
P.O. Box 78 373 Not Applicable |
255222774756
hmasanja@ihi.or.tz |
Dr Anura V Kurpad |
Ulsoor BBMP Maternity Hospital |
Cambridge Road, Ulsoor, Bengaluru, Karnataka 560008 Bangalore |
08049466349
a.kurpad@sjri.res.in |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 3 |
Name of Committee |
Approval Status |
Africa Academy for Public Health,Institutional Review Board of the Ifakara Health Institute,Tanzania |
Approved |
Institutional Review Board of the Ifakara Health Institute, Tanzania |
Approved |
St. Johns Instituitional Ethical Commiittee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Apparent healthy pregnant women in the age group 18-40 years within 20 weeks of gestation |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Active Comparator: Daily 1500 mg Calcium (Standard dose) |
Dietary Supplement: Daily 1500 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. |
Intervention |
Experimental: Daily 500 mg Calcium |
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 |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Female |
Details |
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
|
|
ExclusionCriteria |
Details |
History or signs and/or symptoms of nephrolithiasis
Prior diagnosis of parathyroid disorder or thyroidectomy
Diseases that require digoxin, phenytoin, or tetracycline therapy
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Pharmacy-controlled Randomization |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
Outcome |
TimePoints |
1)Proportion of pregnant women with incident preeclampsia
2) Proportion of preterm birth |
1)Proportion of pregnant women with incident preeclampsia will be assessed by the end of recruitment phase and the last subject delivered.
2) Proportion of preterm birth will be assessed at birth |
|
Secondary Outcome
|
Outcome |
TimePoints |
Pregnancy complications of hypertension such as gestational proteinuria, early onset preeclampsia or eclampsia, placental abruption, HELLP syndrome
Adverse birth outcomes such as early preterm births, low birth weight, small for gestational age birth, still birth, neonatal death and perinatal death
|
During pregnancy
At birth |
|
Target Sample Size
|
Total Sample Size="22000" Sample Size from India="11000" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
15/01/2018 |
Date of First Enrollment (Global) |
05/03/2018 |
Estimated Duration of Trial
|
Years="3" Months="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
The study has not generated any results as yet, so NIL publications at this stage. We anticipate publications to arise directly out of this trial based on the objectives such as: 1) Low dose of calcium intervention is beneficial to women from India during pregnancy in reducing pre-eclampsia and preterm births.
2) Low dose of calcium intervention is beneficial to women from Tanzania during pregnancy in reducing pre-eclampsia and preterm births.
Low dose calcium supplementation improves the acceptability and compliance in India and Tanzania as compared to the standard 1500 mg calcium/d.
|
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. |