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Comparison the effects of different amounts of vitamin D supplementation on calcidiol, Anthropocentric status and body composition in lactation women with body mass index 25 and higher and their infants growth and frequency of visiting a doctor.

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History
# Registration date Revision Id
2 2022-04-13, 1401/01/24 225271
1 2018-11-04, 1397/08/13 65850
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  • Protocol summary

    comparing the growth rate of infants and the chance of infections in infants in mothers who receive different amounts of vitamin D supplementation in this intervention will be the secondary implications of this study.
    Effect of vitamin D supplementation on serum Calcidiol, anthropometric measures and body composition in overweight or obese nursing mothers
    مقایسه میزان رشد شیرخواران و احتمال ابتلا به انواع عفونت در شیرخواران مادرهایی که مقدارهای متفاوتی از مکمل ویتامین دی را در این مداخله دریافت میکنند، از پیامدهای ثانویه مورد بررسی این مطالعه خواهد بود.
    تاثیر مکمل ویتامین D بر کلسیدیول سرم، اندازه های تن سنجی و ترکیب بدن مادران شیرده دارای اضافه وزن یا چاق

  • General information

    empty
    Unfortunately, in the trial registration some primary and secondary outcomes were written by mistake. So we want to revise them.
    empty
    متأسفانه در ثبت کارازمایی برخی از نتایج اولیه و ثانویه به اشتباه نوشته شده است. بنابراین ما می خواهیم آنها را اصلاح کنیم.

  • Primary outcomes

    #1
    empty
    Waist Circumference
    empty
    دور کمر
    empty
    Before the intervention, After the intervention
    empty
    ابتدا و انتهای مطالعه
    empty
    meter-
    empty
    متر
    #2
    empty
    Height
    empty
    قد
    empty
    Before the intervention, After the intervention
    empty
    ابتدا و انتهای مطالعه
    empty
    meter
    empty
    متر
    #3
    empty
    weight
    empty
    وزن
    empty
    Before the intervention, After the intervention
    empty
    ابتدا و انتهای مطالعه
    empty
    body impedance analysis Inbody270
    empty
    دستگاه بادی انالایزر- این بادی 270
    #4
    empty
    fat mass
    empty
    توده چربی
    empty
    Before the intervention, After the intervention
    empty
    ابتدا و انتهای مطالعه
    empty
    body impedance analysis Inbody270
    empty
    دستگاه بادی انالایزر- این بادی 270
    #5
    empty
    fat free mass
    empty
    توده بدون چربی
    empty
    Before the intervention, After the intervention
    empty
    ابتدا و انتهای مطالعه
    empty
    body impedance analysis Inbody270
    empty
    دستگاه بادی انالایزر- این بادی 270
    #6
    empty
    body fat percentages
    empty
    درصد چربی بدن
    empty
    Before the intervention, After the intervention
    empty
    ابتدا و انتهای مطالعه
    empty
    body impedance analysis Inbody270
    empty
    دستگاه بادی انالایزر- این بادی 270
    #7
    empty
    fat mass index
    empty
    ایندکس توده چربی
    empty
    Before the intervention, After the intervention
    empty
    ابتدا و انتهای مطالعه
    empty
    body impedance analysis Inbody270
    empty
    دستگاه بادی انالایزر- این بادی 270
    #8
    empty
    body mass index
    empty
    ایندکس توده بدن
    empty
    Before the intervention, After the intervention
    empty
    ابتدا و انتهای مطالعه
    empty
    body impedance analysis Inbody270
    empty
    دستگاه بادی انالایزر- این بادی 270
    #9
    empty
    relative fat mass
    empty
    اندیکس چربی نسبی
    empty
    Before the intervention, After the intervention
    empty
    ابتدا و انتهای مطالعه
    empty
    RFM index for women calculated as 76 − (20 height × WC in meters)
    empty
    با استفاده از فرمول: 76 − (20 قد× دور کمر به متر)

  • Secondary outcomes

    #1
    Assessment of Neonatal Growth
    Assessment of Neonatal Growth(height, head circumference and weight)
    ارزیابی رشد نوزادان
    ارزیابی رشد نوزادان(قد- وزن-دور سر)
    Data recorded in the case and measurements of height, head circumference and weight at the end of the intervention
    Data recorded in the case before the intervention and measurements of height, head circumference by meter and weight by scale at the end of the intervention
    داده های ثبت شده در پرونده و اندازه گیری ها ی قد ، دور سر و وزن در انتهای مداخله
    داده های ثبت شده در پرونده در ابتدای مداخله و اندازه گیری ها ی قد ، دور سر با متر و وزن با ترازو رو میزی در انتهای مداخله

Protocol summary

Study aim
1. Comparison of changes in serum calcium diol, parathyroid, calcium and phosphorus levels between the three groups. 2. Comparison of changes in waist circumference, weight and body mass index between the three groups 3. Comparison of changes in body fat percentage, body weight (kg), fat mass (kg), visceral fat percentage, visceral fat mass (kg), and fat mass index between the three groups 4. Comparison of changes in height, weight and head circumference of infants in nursing mothers between the three groups 5. Comparison of different infections of the infant (tympanum-nose-eye-throat) between the three groups 6. Comparison of the frequency of visiting a doctor in the newborn between the three groups
Design
In this study, 90 mothers who are admitted to Dehkhoda Hospital for delivery are selected. Patients are randomly assigned to three interventions and control groups .
Settings and conduct
This study is a double-blind randomized clinical trial on mothers in Dehkhoda Hospital in Qazvin province.
Participants/Inclusion and exclusion criteria
All lactating mothers who have a BMI higher than 25, have no illnesses. They also express that they are breastfeeding their infants.
Intervention groups
90 nursing mothers are divided into three groups of 30. Group 1: Placebo Group II: (2000 IU / d) Third group: (4000 IU / D) high limit without risk of taking vitamin D (IOM).
Main outcome variables
Effect of vitamin D supplementation on serum Calcidiol, anthropometric measures and body composition in overweight or obese nursing mothers

General information

Reason for update
Unfortunately, in the trial registration some primary and secondary outcomes were written by mistake. So we want to revise them.
Acronym
IRCT registration information
IRCT registration number: IRCT20140413017254N6
Registration date: 2018-11-04, 1397/08/13
Registration timing: prospective

Last update: 2022-05-08, 1401/02/18
Update count: 1
Registration date
2018-11-04, 1397/08/13
Registrant information
Name
Gity Sotoude
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4293 3333
Email address
gsotodeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2019-01-10, 1397/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of different amounts of vitamin D supplementation on calcidiol, Anthropocentric status and body composition in lactation women with body mass index 25 and higher and their infants growth and frequency of visiting a doctor.
Public title
Comparison the effects of different amounts of vitamin D supplementation on calcidiol, Anthropocentric status and body composition in lactation women with body mass index 25 and higher and their infants growth and frequency of visiting a doctor.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-49 Mother expresses feeding their infant Maternal delivery (between weeks 37 and 42) Body Mass Index (BMI): 25-39.9
Exclusion criteria:
Detected diseases such as cancer, digestive diseases, diabetes, high blood pressure, liver, kidney, autoimmune diseases, inflammation, thyroid Changing in diet over the past 3 months Regular supplementation of vitamin D (at least once a week or supplementing 50,000 units per month) or multivitamins (at least once a week) Smoking or any smoking, even once a week
Age
From 20 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Randomize permuted block randomization blocks Random unit: Individual Randomized layers for stratified randomization: for age (under 30 and over 30) and body mass index (below30 and higher than 30) Randomization Tool: random letters table
Blinding (investigator's opinion)
Double blinded
Blinding description
How to blind the study: Three types of supplements and placebo will be provided with the same shape, color and size. A person who is not involved in the research team will be required to code for a variety of supplements, such as for the subjects and the researchers not be identified. At the end of the data collection, the codes of the supplements will be opened.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central Building of Tehran University of Medical Sciences, Ghods st., Keshavarz Blv., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-10-01, 1397/07/09
Ethics committee reference number
IR.TUMS.VCR.REC.1397.429

Health conditions studied

1

Description of health condition studied
deficiency of vitamin D in lactating women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
calcidiol
Timepoint
Before the intervention, After the intervention
Method of measurement
KIT

2

Description
PTH
Timepoint
Before the intervention, After the intervention
Method of measurement
KIT

3

Description
calcium
Timepoint
Before the intervention, After the intervention
Method of measurement
KIT

4

Description
phosphore
Timepoint
Before the intervention, After the intervention
Method of measurement
KIT

5

Description
Waist Circumference
Timepoint
Before the intervention, After the intervention
Method of measurement
meter-

6

Description
Height
Timepoint
Before the intervention, After the intervention
Method of measurement
meter

7

Description
weight
Timepoint
Before the intervention, After the intervention
Method of measurement
body impedance analysis Inbody270

8

Description
fat mass
Timepoint
Before the intervention, After the intervention
Method of measurement
body impedance analysis Inbody270

9

Description
fat free mass
Timepoint
Before the intervention, After the intervention
Method of measurement
body impedance analysis Inbody270

10

Description
body fat percentages
Timepoint
Before the intervention, After the intervention
Method of measurement
body impedance analysis Inbody270

11

Description
fat mass index
Timepoint
Before the intervention, After the intervention
Method of measurement
body impedance analysis Inbody270

12

Description
body mass index
Timepoint
Before the intervention, After the intervention
Method of measurement
body impedance analysis Inbody270

13

Description
relative fat mass
Timepoint
Before the intervention, After the intervention
Method of measurement
RFM index for women calculated as 76 − (20 height × WC in meters)

Secondary outcomes

1

Description
Assessment of Neonatal Growth(height, head circumference and weight)
Timepoint
Before the intervention, After the intervention
Method of measurement
Data recorded in the case before the intervention and measurements of height, head circumference by meter and weight by scale at the end of the intervention

2

Description
frequency of visiting a doctor
Timepoint
Before the intervention, After the intervention
Method of measurement
doctor

Intervention groups

1

Description
Intervention group: Group 1: Vitamin D supplementation of 2000, IU/d in the form of micro nano capsules from the Nano hayat Pharmacy Company. A daily supplement of 2000 IU/d will be taken as a lunch capsule and a placebo with dinner.
Category
Treatment - Other

2

Description
Intervention group: The second group: two vitamins supplementation, 2000 IU/d, in the form of micro nano capsules from the nano-pharmaceutical company. A daily supplement of 2000IU/d will be consumed as a lunch capsule and a supplement of 2000IU/d.
Category
Treatment - Other

3

Description
The control group contains of 2000 IU/d vitamin D placebo in the form of micro nano from nano hayat pharmacy company. A daily dose of 2000 IU/d placebo will be taken as a lunch capsule and one placebo with dinner.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dehkhoda Superior Hospital
Full name of responsible person
Abolfazl Esfehany
Street address
North Ferdosy
City
Qazvin
Province
Qazvin
Postal code
33413473
Phone
+98 28 3334 2050
Fax
+98 28 3334 1700
Email
info@dehkhodahospital.com
Web page address
http://dehkhodahospital.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
محمدعلی صحرائیان
Street address
Ghods St., Keshavarz Blvd., Central Organization of Tehran university of Medical Sciences
City
Tehran
Province
Tehran
Postal code
2188955698
Phone
+98 21 8163 3698
Email
Info_snsd@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
zohre gerveieeha
Position
phd student of nutrition course in tehran university
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of Nutrition, Tehran University Medical Sciences, Naderi St., Keshavar Blvd., Tehran
City
qazvin
Province
Qazvin
Postal code
1439957181
Phone
+98 28 3369 0457
Email
z.gerveiee1989@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Gity Sotodeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition, Tehran University of Medical Sciences, Naderi St., Keshavar Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
2188955698
Phone
+98 21 8895 5742
Email
gsotodeh@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
zohre gerveieeha
Position
phd candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
naderi-razi alley
City
qazvin
Province
Qazvin
Postal code
3414714493
Phone
+98 28 3369 0457
Email
z.gerveiee1989@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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