Clinical Trial Details (PDF Generation Date :- Thu, 15 Dec 2022 03:33:55 GMT)

CTRI Number CTRI/2022/10/046723 [Registered on: 21/10/2022] - Trial Registered Prospectively

Last Modified On 08/11/2022
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Other (Specify) [Health functional food]
Study Design Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study Effect of Probiotic on Bacterial Vaginosis
Scientific Title of A Double blind, Randomized, Placebo-controlled, Parallel Clinical Trial to Evaluate the Cli
Study Efficacy and Safety of Vaginal Probiotic Capsule (LABTHERA-001) in patients with Bacte
Vaginosis

Secondary IDs if Any Secondary ID

21PR0068-008 Version 1.1 Date 13 June 2022
NIL

Details of Principal Details of Principal Investigator

Investigator or overall Name Dr Sunitha B
Trial Coordinator
Designation Obstetrician & Gynaecologist
(multi-center study)
Affiliation Milann Hospital
Address # 1109, 24th main road, TMC layout, 1st Phase
Bengaluru, Karnataka
Bangalore
KARNATAKA
560078
India

Phone 9845354608
Fax
Email [email protected]

Details Contact Details Contact Person (Scientific Qu

Person (Scientific Name Dr Jang Yul Kwak
Query)
Designation Director
Affiliation Syncorp Health Pvt Ltd
Address Building # 06, 3rd floor 2nd Main Road, opposite
Biologicals, Sarvobhogam Nagar, Arekere, Beng
Bangalore
KARNATAKA
560076
India

Phone 8970888899
Fax
Email [email protected]

Details Contact Details Contact Person (Public Quer

Person (Public Query)
 Person (Public Query) Name Subham Dutta
Designation Director
Affiliation Syncorp Health Pvt Ltd
Address Building # 06, 3rd floor 2nd Main Road, opposite
Biologicals, Sarvobhogam Nagar, Arekere, Beng
Bangalore
KARNATAKA
560076

India
Phone 08049774772
Fax
Email [email protected]

Source of Monetary or Source of Monetary or Material Supp

Material Support > Research Mentor Co. Ltd, 905, SKV1 tower, 25, Yeonmujang 5 ga-gil, Seongdong-gu, S
Republic of South Korea

Primary Sponsor Primary Sponsor Details

Name Atogen Co., Ltd.
Address #201, 11-8, Techno 1-ro, Yuseong-gu, Daejeon,
South Korea
Type of Sponsor Pharmaceutical industry-Global

Details of Secondary Name

Sponsor NIL
Countries of List of Countries
Recruitment India

Sites of Study Name of Principal Name of Site

Investigator
Dr Anu Sadashiv B Milann fertility & birthing
hospital
 Dr Sunitha B Milann Hospital

Dr Premlata B Sanjeevini Hospital

Kamalapur

Details of Ethics Name of Committee Approval Status

Committee
Milann fertility & birthing Submittted/Under
hospital Institutional Review
Ethics Committee
Milann Hospital Approved

Institutional Ethics
Committee
Sanjeevini Hospital Approved
Institutional Ethics
Committee

Regulatory Clearance Status

Status from DCGI Not Applicable
Health Condition / Health Type
Problems Studied Patients

Intervention / Type Name

Comparator Agent Intervention LABTHERA-001 Intravaginal
Capsule
 Intervention LABTHERA-001 Intravaginal
Capsule

Comparator Agent Placebo

Inclusion Criteria Inclusion Criteria

Age From 20.00 Year(s)
Age To 45.00 Year(s)
Gender Female
Details 1. Non-pregnant, non-breastfeeding females be
and 45 years, inclusive willing to participate in s
written informed consent.<br/> 2. Women of chi
must agree to practice reliable contraception for
before enrollment through 30 days following trea
Agree to abstain from sexual intercourse 24 hou
and 6 hours after IP insertion and agrees to follo
acceptable method of contraception. <br/> 4. Pr
of Bacterial Vaginosis (as per Amsel Criteria).<b
specimen should have a Nugent score of greate
4<br/> 6. Women who are currently not menstru
to have menstruation within 17 days from screen
understand and comply with planned study proc
Willing to abstain from insertion of tampons, dou
intravaginal medications or objects during study
serum or urine pregnancy test<br/> 10. Provide
consent before initiation of any study procedure
all study visits<br/> 11. No known history of HIV
refrigerator to store the investigational product

Exclusion Criteria Exclusion Criteria

Details 1)Potential participants who ar
child-bearing potential unwilling
control or abstin
2)Patients with vaginal, vulv
according to
14)Any other condition that in th
 justify the patient’s participation in the study
judgement, may confound the interpretation of c
based on Liquid Based Cytology
3)Patients with a history of regional enteritis, ulc
history of C. difficile associated diarrhea
4)Patients with known current drug or alcohol ab
impact study compliance
5)Mixed vaginal infections, including bacterial va
trichomoniasis or coexistent infections with geni
cervicitis based on Liquid Based Cytology
6)Self-reported abnormal Papanicolaou smear (
the preceding 12 months
7)History of diabetes mellitus
8)Immunocompromised patients, including those
immunodeficiency virus seropositivity or with clin
acquired immunodeficiency syndrome or its rela
HIV test
9)Patients who had taken oral or intravenous an
4weeks or used topical vaginal antifungal drugs
enrollment
10)Terminally ill patients or patients with severe
kinase values >3 X upper limit of normal laborat
(AST, ALT values >3 X upper limit of normal lab
(creatinine > 2mg/dl) or history of cerebrovascul
malignancy, chronic uncontrolled systemic disea
hypertension, collagen disorders, etc. or any oth
illness.
11)Patients with known sensitivity to any of the a
ingredients in the study drug
12)Patients with a history of any severe acute o
psychiatric condition or laboratory abnormality th
the risk associated with trial participation or stud
administration or could interfere with the interpre
and, in the judgment of the Investigator, would m
inappropriate for entry into the trial.
13)Patients who have participated in a new drug
months

Method of Generating Computer generated randomization

Random Sequence
Method of Sequentially numbered, sealed, opaque envelopes
Concealment
Blinding/Masking Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome Outcome
1. Reduction in Amsel Criteria
2. Reduction in Nugent Score
3. Microbiome restoration through vaginal
specimen
4. LABTHERA-001 colonization through qPCR

Secondary Outcome Outcome

 Number of positive Bacterial Vaginosis

Number of negative Bacterial vaginosis

Acceptability of treatment
a. Proportion of participants who comply with the
complete dose regimen in each study arm as
assessed
by subject reporting through diary card

b. Self-administered questionnaire about

acceptability
of the study product in each study arm

Tolerability of treatment:Tolerability will be

assessed by proportion of participants
who discontinue investigational product early in
each
study arm due to local adverse events (local
adverse
events includes signs and symptoms of vaginal
origin)

Improvement in self-reported vaginal signs and

symptoms
will be assessed for vaginal itch, vaginal burning,
itch of
external genitals, burning of external genitals,
vaginal
discharge, urination disorder and painful
intercourse on a
scale of 0 to 10 (0: absence of signs and
symptoms & 10:
maximum discomfort)

Target Sample Size Total Sample Size=60

Sample Size from India=60
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated
Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated

Phase of Trial Phase 2

Date of First 31/10/2022
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Months=0
Days=0
 Years=1
Trial Months=0
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Not Yet Recruiting
Trial (India)
Publication Details None Yet
Brief Summary Bacterial vaginosis (BV) is an infection of the vagina characterized by overgrowth of certa
bacteria which leads to change in normal balance of vaginal microbiome. The signs and s
of Bacterial Vaginosis includes thin, grey, white or green vaginal discharge, foul-smelling
vaginal odor, vaginal itching or burning sensation during urination. The rationale of this stu
evaluate the clinical efficacy and safety of vaginal probiotic capsule (LABTHERA-001) in B
Vaginosis.

Clinical Trial Details (PDF Generation Date :- Thu, 15 Dec 2022 03:34:04 GMT)

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 A prospective, randomized, open-label, active-controlled, clinical study to evaluate the tol
Study and incidence of pregnancy complications up on Lipocal supplementation in pregnant wom
Secondary IDs if Any Secondary ID
21PR0075-008 Version: 1.0 18-Oct-2022

Details of Principal Details of Principal Investigator

Investigator or overall Name Dr Premlata B Kamalapur
Trial Coordinator
Designation Senior Consultant and Medical Director
(multi-center study)
 (multi-center study)
Affiliation Sanjeevini Hospital
Address Room No 7, Ground Floor, Department of Obste
Gynaecologist, # 761, 7th Main Road, Last Bus
layout, Bengaluru, Karnataka - 560086
Bangalore
KARNATAKA
560086
India

Phone 9845699687
Fax
Email [email protected]

Details Contact Details Contact Person (Scientific Qu

Person (Scientific Name Venkatasubbaiah Narra
Query)
Designation DGM RA
Affiliation G.C Chemie Pharmie Limited
Address G.C Chemie Pharmie Limited, 5/C, Shree Laxm
New Link Road, Andheri West, Mumbai
Mumbai
MAHARASHTRA
400053
India

Phone 8657443730
Fax
Email [email protected]

Details Contact Details Contact Person (Public Quer

Person (Public Query) Name Subham Dutta
Designation Director
Affiliation Syncorp Health Pvt Ltd
Address Building # 06, 3rd floor 2nd Main Road, opposite
Biologicals, Sarvobhogam Nagar, Arekere, Beng
Bangalore
KARNATAKA
560076
India

Phone 08049774772
Fax
Email [email protected]

Source of Monetary or Source of Monetary or Material Supp

Material Support
 Material Support > G.C Chemie Pharmie Limited, Mumbai

Primary Sponsor Primary Sponsor Details

Name G.C Chemie Pharmie Limited
Address 5/C, Shree Laxmi Industrial Estate, New Link Ro
Mumbai 400053
Type of Sponsor Pharmaceutical industry-Indian

Details of Secondary Name

Sponsor NIL

Countries of List of Countries

Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Dr Premlata B Sanjeevini Hospital
Kamalapur

Details of Ethics Name of Committee Approval Status

Committee
ETHICS COMMITTEE Approved
ON HUMAN
RESEARCH SH-IEC

Regulatory Clearance Status

Status from DCGI Not Applicable
Health Condition / Health Type
Problems Studied Patients

Intervention / Type Name

Comparator Agent Intervention Lipocal microencapsulated
calcium

Comparator Agent Shelcal 500

Inclusion Criteria 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 a
inclusive) willing to participate in study and prov
 consent. <br/> 2. Pregnant women at 20th week
care visit (ANC) visit at study clinics.
Exclusion Criteria Exclusion Criteria
Details 1. No medical contraindications to continuing pr
2. Treatment with antitubercular and anti-epilept
3. History of pre-eclampsia & eclampsia
4. History or signs and/or symptoms of nephrolit
5. Prior diagnosis of parathyroid disorder or thyr
6. Diseases that require digoxin, phenytoin, or te
7. History of chronic liver disease
8. History of renal disease & no known uterine a
9. No history of cervical conization
10. Obesity (BMI 30.0 and higher)
11. Diagnostic history of Type I & Type II Diabet
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 particip

Method of Generating Permuted block randomization, fixed

Random Sequence
Method of Sequentially numbered, sealed, opaque envelopes
Concealment
Blinding/Masking Open Label
Primary Outcome Outcome
1. Modified Bovenschen GI Symptoms
Questionnaire
2. Tolerability assessed via a five-point Facial
Hedonic Scale for
Taste (palatability) Swallowability Mouthfeel
(texture) & Smell

Secondary Outcome Outcome

Preeclampsia

Preterm Birth
Information of any diagnosed preeclampsia
during unscheduled ANC visit
Placental abruption with grade
 IUGR
Early preterm birth
Low birth weight
Small for gestational age birth
Still birth
Neonatal death
Perinatal death
Bristol Stool Questionnaire

Target Sample Size Total Sample Size=40

Sample Size from India=40
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated
Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated

Phase of Trial Phase 3

Date of First 05/12/2022
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Trial Months=6
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Not Yet Recruiting
Trial (India)
Publication Details None Yet
Brief Summary Physiological changes occur in pregnancy and maintaining maternal homeostasis and en
growth and development have direct association on calcium metabolism. Increased intest
calcium absorption, increased urine calcium excretion, and increased bone turnover are a
the calcium homeostatic response during pregnancy. From 6th month onwards, with the t
trimester being bulk of calcium utilized, when fetal skeletal growth peaks at 250 to 350 mi
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 pregna
with low dietary calcium intake. Calcium supplementation during pregnancy for women wh
get enough calcium from their diet has a significant benefit in reducing preeclampsia and
births, as well as enhancing maternal and child bone health.
 PDF of Trial
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3:55 GMT)

al Registered Prospectively

el Clinical Trial to Evaluate the Clinical

HERA-001) in patients with Bacterial

Identifier
Protocol Number
NIL
Details of Principal Investigator

Gynaecologist
al
main road, TMC layout, 1st Phase J P Nagar,
rnataka

[email protected]
s Contact Person (Scientific Query)
wak

h Pvt Ltd
3rd floor 2nd Main Road, opposite to British
arvobhogam Nagar, Arekere, Bengaluru, Karnataka

yncorp.in
ils Contact Person (Public Query)
h Pvt Ltd
3rd floor 2nd Main Road, opposite to British
arvobhogam Nagar, Arekere, Bengaluru, Karnataka

page 1 / 5

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@syncorphealth.com
ce of Monetary or Material Support
mujang 5 ga-gil, Seongdong-gu, Seoul,

Primary Sponsor Details

d.
echno 1-ro, Yuseong-gu, Daejeon, 34015 Republic of

al industry-Global
Address
NIL

Site Address Phone/Fax/Email

Room No. 4, Ground 9945508681

Floor, Department of [email protected]
Obstetrician &
Gynaecologist, #07, E
Park Road, Kumara
park east, Seshadri
Puram, Bengaluru,
Karnataka - 560001
Bangalore
KARNATAKA
 Room No 5, Ground 9845354608
Floor, Department of dr.sunithamahesh@gm
Obstetrician & ail.com
Gynaecologist, # 1109,
24th main road, TMC
layout, 1st Phase J P
Nagar, Bengaluru,
Karnataka - 560078
Bangalore
KARNATAKA

Room No 7, Ground 9845699687

Floor, Department of drpremalata@sanjeevin
Obstetrician & ihospital.com
Gynaecologist, # 761,
7th Main Road, Last
Bus stop, Mahalakshmi
layout, Bengaluru,
Karnataka - 560086
Bangalore
KARNATAKA

Date of Approval Is Independent Ethics

Committee?
No Date Specified No

02/11/2022 No

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13/10/2022 No

Date
No Date Specified
Condition
Vaginitis, vulvitis and vulvovaginitis in diseases
classified elsewhere

Details
RA-001 Intravaginal Group A: LABTHERA-001
Capsule : 6×10 to the power of
9 CFU Once daily at night for 7
consecutive days followed by
twice a week at night for 3
weeks. Group B:
LABTHERA-001 Capsule : 1×10
to the power of 9 CFU Once
daily at night for 7 consecutive
days followed by twice a week
at night for 3 weeks.
 RA-001 Intravaginal Group A: LABTHERA-001
Capsule : 6×10 to the power of
9 CFU Once daily at night for 7
consecutive days followed by
twice a week at night for 3
weeks. Group B:
LABTHERA-001 Capsule : 1×10
to the power of 9 CFU Once
daily at night for 7 consecutive
days followed by twice a week
at night for 3 weeks.

Capsule 0 CFU Once daily at

night for 7 consecutive days
followed by twice a week at
night for 3 weeks.

Inclusion Criteria

nt, non-breastfeeding females between the ages of 20

inclusive willing to participate in study and provide
ed consent.<br/> 2. Women of childbearing potential
practice reliable contraception for the 28-day period
ent through 30 days following treatment. <br/> 3.
ain from sexual intercourse 24 hours before each visit
ter IP insertion and agrees to follow medically
ethod of contraception. <br/> 4. Presenting with signs
aginosis (as per Amsel Criteria).<br/> 5. Vaginal
uld have a Nugent score of greater than or equal to
men who are currently not menstruating or expected not
ruation within 17 days from screening<br/> 7. Able to
nd comply with planned study procedures<br/> 8.
ain from insertion of tampons, douches, or other
edications or objects during study<br/> 9. Negative
e pregnancy test<br/> 10. Provide written informed
e initiation of any study procedures and be available for
<br/> 11. No known history of HIV<br/> 12. Have a
store the investigational product

Exclusion Criteria
1)Potential participants who are pregnant or breastfeeding, or if of
child-bearing potential unwilling to practice acceptable means of birth
control or abstinence during the study
2)Patients with vaginal, vulvar, or genitourinary condition that,
according to the Investigators
14)Any other condition that in the opinion of the investigator does not

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ent’s participation in the study
ay confound the interpretation of clinical response
id Based Cytology
h a history of regional enteritis, ulcerative colitis, or a
fficile associated diarrhea
h known current drug or alcohol abuse that could
ompliance
al infections, including bacterial vaginosis and
or coexistent infections with genital herpes and
d on Liquid Based Cytology
d abnormal Papanicolaou smear (grade 3 or more) in
12 months
abetes mellitus
promised patients, including those with human
ency virus seropositivity or with clinically diagnosed
unodeficiency syndrome or its related complex as per

o had taken oral or intravenous antifungal agents within

ed topical vaginal antifungal drugs within 1 week before

ill patients or patients with severe cardiac (creatine

>3 X upper limit of normal laboratory values), hepatic
ues >3 X upper limit of normal laboratory values) renal
mg/dl) or history of cerebrovascular disease,
hronic uncontrolled systemic disease e.g.,
collagen disorders, etc. or any other serious medical

th known sensitivity to any of the active or inactive

the study drug
th a history of any severe acute or chronic medical or
ndition or laboratory abnormality that could increase
ated with trial participation or study treatment
or could interfere with the interpretation of trial results
gment of the Investigator, would make the patient
or entry into the trial.
ho have participated in a new drug study in the past 3

ntry Operator Blinded

Timepoints
1. Visit 1,2,3,4,5,6 and 7
2. Visit 1,2,3,4,5,6 and 7
3. Visit 1,2,3,4,5,6 and 7
4. Visit 1,2,3,4,5,6 and 7

Timepoints
 Visit 1,2,3,4,5,6 and 7

Visit 1,2,3,4,5,6 and 7

Visit 1,2,3,4 and 5

page 4 / 5

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Visit 1,2,3,4 and 5

Visit 1,2,3,4,5,6 and 7

le only for Completed/Terminated trials

le only for Completed/Terminated trials
aracterized by overgrowth of certain types of
ginal microbiome. The signs and symptoms
n vaginal discharge, foul-smelling "fishy"
g urination. The rationale of this study is to
otic capsule (LABTHERA-001) in Bacterial

page 5 / 5

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4:04 GMT)

al Registered Prospectively

women
d, clinical study to evaluate the tolerability
l supplementation in pregnant women
Identifier
Protocol Number
Details of Principal Investigator
Kamalapur
tant and Medical Director
spital
round Floor, Department of Obstetrician &
, # 761, 7th Main Road, Last Bus stop, Mahalakshmi
uru, Karnataka - 560086

sanjeevinihospital.com
s Contact Person (Scientific Query)
aiah Narra

Pharmie Limited
Pharmie Limited, 5/C, Shree Laxmi Industrial Estate,
d, Andheri West, Mumbai

RA

ccpl.com
ils Contact Person (Public Query)

h Pvt Ltd
3rd floor 2nd Main Road, opposite to British
arvobhogam Nagar, Arekere, Bengaluru, Karnataka

page 1 / 4

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@syncorphealth.com
ce of Monetary or Material Support
 Primary Sponsor Details
Pharmie Limited
xmi Industrial Estate, New Link Road, Andheri West,
53
al industry-Indian
Address
NIL

Site Address Phone/Fax/Email

Room No 7, Ground 9845699687

Floor, Department of drpremalata@sanjeevin
Obstetrician & ihospital.com
Gynaecologist, # 761,
7th Main Road, Last
Bus stop, Mahalakshmi
layout, Bengaluru,
Karnataka - 560086
Bangalore
KARNATAKA

Date of Approval Is Independent Ethics

Committee?
19/11/2022 No

Date
No Date Specified
Condition
Pregnancy related conditions, unspecified
Details
microencapsulated 500mg once daily from 20th
week ANC visit to till childbirth /
parturition (Total duration of
intervention is 20 weeks)
500 500mg once daily from 20th
week ANC visit to till childbirth /
parturition (Total duration of
intervention is 20 weeks)

Inclusion Criteria

males between the ages of ?18 and 40 years (both

ng to participate in study and provide written informed
 page 2 / 4

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> 2. Pregnant women at 20th weeks attending antenatal

C) visit at study clinics.
Exclusion Criteria
contraindications to continuing pregnancy.
with antitubercular and anti-epileptic drugs.
re-eclampsia & eclampsia
gns and/or symptoms of nephrolithiasis
osis of parathyroid disorder or thyroidectomy
at require digoxin, phenytoin, or tetracycline therapy
hronic liver disease
enal disease & no known uterine anomaly
of cervical conization
MI 30.0 and higher)
history of Type I & Type II Diabetes
history of hypertension
any autoimmune disease
th multiple pregnancy.
history of fetal anomalies.
condition that in the opinion of the
oes not justify the patients participation in the study.

Timepoints
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.

Timepoints
visit 1, visit 5, visit 6, visit 7, visit 8, visit 9.

Throughout the study

visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7,
visit 8 and visit 9.
Throughout the study
 visit 1, visit 5, visit 6, visit 7, visit 8 and visit 9.
Start of study and up to 32 weeks
Throughout the study
visit 1, visit 5, visit 6, visit 7, visit 8 and visit 9
Throughout the study
visit 9
visit 6, visit 7, visit 8 and visit 9
visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7,
visit 8, visit 9

le only for Completed/Terminated trials

le only for Completed/Terminated trials

page 3 / 4

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ing maternal homeostasis and enabling fetal

cium metabolism. Increased intestinal
and increased bone turnover are all part of
om 6th month onwards, with the third
tal growth peaks at 250 to 350 milligrams
Pregnant women’s daily calcium
mends 1.5 g to 2 g daily for pregnant women
n during pregnancy for women who do not
efit in reducing preeclampsia and preterm
alth.
page 4 / 4