| CTRI Number |
CTRI/2022/12/047860 [Registered on: 02/12/2022] Trial Registered Prospectively |
| Last Modified On: |
01/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Calcium Supplement] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on effect of calcium supplementation on pregnant women |
|
Scientific Title of Study
|
A prospective, randomized, open-label, active-controlled, clinical study to evaluate the tolerability and incidence of pregnancy complications up on Lipocal supplementation in pregnant women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 21PR0075-008 Version: 1.0 18-Oct-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Premlata B Kamalapur |
| Designation |
Senior Consultant and Medical Director |
| Affiliation |
Sanjeevini Hospital |
| Address |
Room No 7, Ground Floor,
Department of Obstetrician & Gynaecologist,
# 761, 7th Main Road, Last Bus stop, Mahalakshmi layout,
Bengaluru, Karnataka - 560086
Bangalore
KARNATAKA
560086
India |
| Phone |
9845699687 |
| Fax |
|
| Email |
drpremalata@sanjeevinihospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Venkatasubbaiah Narra |
| Designation |
DGM RA |
| Affiliation |
G.C Chemie Pharmie Limited |
| Address |
G.C Chemie Pharmie Limited, 5/C,
Shree Laxmi Industrial Estate,
New Link Road, Andheri West, Mumbai
Mumbai
MAHARASHTRA
400053
India |
| Phone |
8657443730 |
| Fax |
|
| Email |
regulatory@gccpl.com |
|
Details of Contact Person
Public Query
|
| Name |
Subham Dutta |
| Designation |
Director |
| Affiliation |
Syncorp Health Pvt Ltd |
| Address |
Building # 06, 3rd floor 2nd Main Road, opposite to British Biologicals, Sarvobhogam Nagar, Arekere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560076
India |
| Phone |
08049774772 |
| Fax |
|
| Email |
subham.dutta@syncorphealth.com |
|
|
Source of Monetary or Material Support
|
| G.C Chemie Pharmie Limited, Mumbai |
|
|
Primary Sponsor
|
| Name |
G.C Chemie Pharmie Limited |
| Address |
5/C,
Shree Laxmi Industrial Estate,
New Link Road, Andheri West, Mumbai 400053 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Premlata B Kamalapur |
Sanjeevini Hospital |
Room No 7, Ground Floor,
Department of Obstetrician & Gynaecologist,
# 761, 7th Main Road, Last Bus stop, Mahalakshmi layout,
Bengaluru, Karnataka - 560086
Bangalore
KARNATAKA |
9845699687
drpremalata@sanjeevinihospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE ON HUMAN RESEARCH SH-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lipocal microencapsulated calcium |
500mg once daily from 20th week ANC visit to till childbirth / parturition (Total duration of intervention is 20 weeks) |
| Comparator Agent |
Shelcal 500 |
500mg once daily from 20th week ANC visit to till childbirth / parturition (Total duration of intervention is 20 weeks) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant females between the ages of ≥18 and 40 years (both inclusive) willing to participate in study and provide written informed consent.
2. Pregnant women at 20th weeks attending antenatal care visit (ANC) visit at study clinics. |
|
| ExclusionCriteria |
| Details |
1. No medical contraindications to continuing pregnancy.
2. Treatment with antitubercular and anti-epileptic drugs.
3. History of pre-eclampsia & eclampsia
4. History or signs and/or symptoms of nephrolithiasis
5. Prior diagnosis of parathyroid disorder or thyroidectomy
6. Diseases that require digoxin, phenytoin, or tetracycline therapy
7. History of chronic liver disease
8. History of renal disease & no known uterine anomaly
9. No history of cervical conization
10. Obesity (BMI 30.0 and higher)
11. Diagnostic history of Type I & Type II Diabetes
12. Diagnostic history of hypertension
13. History of any autoimmune disease
14. Subject with multiple pregnancy.
15. Diagnostic history of fetal anomalies.
16. Any other condition that in the opinion of the
investigator does not justify the patients participation in the study. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Modified Bovenschen GI Symptoms Questionnaire
2. Tolerability assessed via a five-point Facial Hedonic Scale for
Taste (palatability) Swallowability Mouthfeel (texture) & Smell |
1. visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7, visit 8, visit 9.
2. visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7, visit 8, visit 9. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Preeclampsia
|
visit 1, visit 5, visit 6, visit 7, visit 8, visit 9. |
| Preterm Birth |
Throughout the study |
| Information of any diagnosed preeclampsia during unscheduled ANC visit |
visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7, visit 8 and visit 9. |
| Placental abruption with grade |
Throughout the study |
| IUGR |
visit 1, visit 5, visit 6, visit 7, visit 8 and visit 9. |
| Early preterm birth |
Start of study and up to 32 weeks |
| Low birth weight |
Throughout the study |
| Small for gestational age birth |
visit 1, visit 5, visit 6, visit 7, visit 8 and visit 9 |
| Still birth |
Throughout the study |
| Neonatal death |
visit 9 |
| Perinatal death |
visit 6, visit 7, visit 8 and visit 9 |
| Bristol Stool Questionnaire |
visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7, visit 8, visit 9 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/12/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Physiological changes occur in pregnancy and maintaining
maternal homeostasis and enabling fetal growth and development
have direct association on calcium metabolism. Increased
intestinal calcium absorption, increased urine calcium excretion,
and increased bone turnover are all part of the calcium
homeostatic response during pregnancy. From 6th month
onwards, with the third trimester being bulk of calcium utilized,
when fetal skeletal growth peaks at 250 to 350 milligrams
transferred from pregnant mother and baby every day. Pregnant
women’s daily calcium consumption has been reported to be low.
WHO recommends 1.5 g to 2 g daily for pregnant women with
low dietary calcium intake. Calcium supplementation during
pregnancy for women who do not get enough calcium from their
diet has a significant benefit in reducing preeclampsia and
preterm births, as well as enhancing maternal and child bone
health. |