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Comparison of the effect of vitamin D and vitamin C cream and their composition on pregnancy striae in first pregnant women

Protocol summary

Study aim
Comparison of the effect of vitamin D ,vitamin C creams and their combined on pregnancy striae in first pregnant women
Design
Clinical trial with control group, with parallel groups, three-way blind, randomized,phase3 on 120patients.For randomization,the seal envelope site is used by specifying the number of 8and16 random blocks
Settings and conduct
The study population was first pregnant women aged 20-18 weeks who referred to Shahid Akbarabadi Hospital. Thus, follow-up will be done during pregnancy for 4 months. Samples will be randomly assigned to one of the groups: vitamin C+D cream or vitamin D or vitamin C or placebo group. Before starting the study, a hypothetical list of 120 items was prepared through the random block method by sealing the envelope site by specifying the number of blocks of 8 and 16, for participants in 4 groups of 30, A, B, C, and D will be created. Numbered, matte, and sealed envelopes will be used to hide the allocation and protect the blind. In this way, the participants will be blinded. One group of cream with code A will be given to another group with cream with code B, another group with cream with code C, and another group with cream with code D.Since this study is a three-blind clinical trial, for the blinding of the researcher and analyst, the worms will be identified with codes A, B, C, D and the type of worms will not be specified.
Participants/Inclusion and exclusion criteria
Healthy first pregnant women in the age group of 20-40 years,18-20 weeks and body mass index 18.5-25;Have a minimum literacy;Known systemic or underlying disease;Multiple pregnancy;History of pre-striae skin diseases;History of allergies to vitamins D&C;Maternal polyhydramnios;Diagnosis of macrosomia
Intervention groups
Intervention groups Consumer of vitamin D Consumer of vitamin C Consumer of vitamin D+C Placebo group Consumer of base cream
Main outcome variables
Pregnancy striae

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220509054799N1
Registration date: 2022-06-06, 1401/03/16
Registration timing: registered_while_recruiting

Last update: 2022-06-06, 1401/03/16
Update count: 0
Registration date
2022-06-06, 1401/03/16
Registrant information
Name
Hadis Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 2918
Email address
taheri.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of vitamin D and vitamin C cream and their composition on pregnancy striae in first pregnant women
Public title
Comparison of the effect of vitamin D and vitamin C cream and their composition on pregnancy striae in first pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Primigravid healthy pregnant women The age group of 20-40 years, 18-20 weeks pregnancy Body mass index 18.5-25 Have a minimum literacy
Exclusion criteria:
Known systemic or underlying disease (such as gestational diabetes, preeclampsia, adrenal insufficiency, and Cushing's disease) Multiple pregnancies History of pre-striae skin diseases History of allergies to vitamin D and C. Maternal polyhydramnios Diagnosis of macrosomic embryos
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Before starting the study, a hypothetical list of 120 pieces was prepared and through the random block method by seal envelope site by specifying the number of blocks of 8 and 16, for participants in four groups of 30 worms A and worm B And worm C and worm D will be created. Numbered, matte and sealed envelopes will be used to hide the allocation and protect the blind. The envelopes will be opened in the order in which the participants enter the study. Eventually, 30 people will enter each group. One group will be given cream with code A, another group with cream with code B, another group with cream with code C and another group with cream with code D. These creams will be prepared by the order of the researcher and by a pharmaceutical consultant in the School of Traditional Medicine of Iran. Since this study is a three-blind clinical trial, the worms will be identified by codes A, B, C and D, and the type of worms will not be identified.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Numbered, matte and sealed envelopes will be used to hide the allocation and protect the blind. The envelopes will be opened in the order in which the participants enter the study. Eventually, 30 people will enter each group. One group of worms with code A will be given another group of worms with code B, another group with worms with code C and another group with worms with code D, thus blinding the participants. These creams will be prepared by the order of the researcher and by a pharmaceutical consultant in the School of Traditional Medicine of Iran. Since this study is a three-blind clinical trial, in order to keep the researcher and analyzer of the worms blind, the codes A, B, C and D will be specified and the type of worms will not be specified.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemmat Highway between Chamran and Sheikh Fazlollah Iran University of Medical Sciences Headquarters Fifth Floor
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-06-01, 1401/03/11
Ethics committee reference number
IR.IUMS.REC.1401.215

Health conditions studied

1

Description of health condition studied
Pregnancy striae
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Striae are skin changes that occur in situations where the skin is under the physical pull of sudden growth during adolescence, pregnancy, or in conditions such as Cushing's syndrome, in which severe hormonal changes occur in the body. In mid-pregnancy, reddish, slightly sunken streaks usually form on the skin of the abdomen and sometimes on the skin above the breasts and thighs. These are called stria gravidarum or stretch marks. These lines lose their pigmentation some time after delivery, turn oyster white, and eventually remain atrophic, slightly wrinkled, and sunken over time.
Timepoint
Before, 4, 8, 12 and 16 weeks after the start of the intervention
Method of measurement
In this study, the practical definition is in accordance with the above theoretical definition and the Atwal scale is used to measure this variable. This scale is used to classify women based on the severity of striae. Based on this system, the abdomen, breast, thighs and buttocks are examined for the severity of erythema and the number of stretch marks. The maximum score in each area is 6. The total score is 0-3 without striae or without significant striae, the total score is 4-9 mild striae, the total score is 10-15 moderate striae and the total score is more than 16 is severe striae.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Consumer of vitamin D - Participants receive topical vitamin D 5000 units per 100 grams of uranda base cream (containing alcohol, glycerin, triethanolamine, mono-stearic acid, white Vaseline and distilled water) for 4 months. This cream will be prepared by the order of the researcher and by a pharmaceutical consultant in the School of Traditional Medicine of Iran. How to use it is that this cream for 4 months daily, twice a day every 12 hours using the finger, topically and gently and without massaging the skin of the abdomen, thighs, breasts and buttocks to cover Apply all those areas with a thin layer of cream and people are asked not to wash it after use until it is absorbed.
Category
Prevention

2

Description
Intervention group: Consumer of vitamin C - Participants receive 3% topical vitamin C in 100 g of uranda base cream (containing alcohol, glycerin, triethanolamine, mono-stearic acid, white Vaseline and distilled water) for 4 months. This cream will be prepared by the order of the researcher and by a pharmaceutical consultant in the School of Traditional Medicine of Iran. How to use it is that this cream for 4 months daily, twice a day every 12 hours using the finger, topically and gently and without massaging the skin of the abdomen, thighs, breasts and buttocks to cover Apply all those areas with a thin layer of cream and people are asked not to wash it after use until it is absorbed.
Category
Prevention

3

Description
Intervention group: Consumer of Vitamin C + D - Participants of topical vitamin D 5000 units in 100 g of Orande base cream (containing alcohol, glycerin, triethanolamine, monostaric acid, white Vaseline and distilled water) with topical vitamin C 3%, Receive for 4 months. This cream will be prepared by the order of the researcher and by a pharmaceutical consultant in the School of Traditional Medicine of Iran. How to use it is that this cream for 4 months daily, twice a day every 12 hours using the finger, topically and gently and without massaging the skin of the abdomen, thighs, breasts and buttocks to cover Apply all those areas with a thin layer of cream and people are asked not to wash it after use until it is absorbed.
Category
Prevention

4

Description
Control group: Base Cream Consumer - Participants receive Eurend Base Cream containing alcohol, glycerin, triethanolamine, mono-stearic acid, white Vaseline and distilled water for 4 months. This cream will be prepared by the order of the researcher and by a pharmaceutical consultant in the School of Traditional Medicine of Iran. How to use it is that this cream for 4 months, daily, twice a day for 12 hours using a finger, topically and gently and without massaging the skin of the abdomen, thighs, breasts and buttocks to the cover Apply all those areas with a thin layer of cream and people are asked not to wash it after use until it is absorbed.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Akbarabadi hospital
Full name of responsible person
Ms Salamatmanesh
Street address
Molavi St, not reached the Molavi Crossroads
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com
Web page address
https://crta.iums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hossein Keivani
Street address
Hemmat Highway between Chamran and Sheikh Fazlollah Iran University of Medical Sciences Headquarters Fifth Floor
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Fax
+98 21 8862 2703
Email
research@iums.ac.ir
Web page address
https://res.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
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
Iran University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Kheirkhah
Position
Assistant Professor of Midwifery
Latest degree
Medical doctor
Other areas of specialty/work
Midwifery
Street address
Vali Asr Street, above Vanak Square, Rashid Yasemi Street Iranian School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
kheirkhah.m@iums.ac.ir
Web page address
https://fnm.iums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Kheirkhah
Position
Assistant Professor of Midwifery
Latest degree
Medical doctor
Other areas of specialty/work
Midwifery
Street address
Vali Asr Street, above Vanak Square, Rashid Yasemi Street Iranian School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
kheirkhah.m@iums.ac.ir
Web page address
https://fnm.iums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Kheirkhah
Position
Assistant Professor of Midwifery
Latest degree
Medical doctor
Other areas of specialty/work
Midwifery
Street address
Vali Asr Street, above Vanak Square, Rashid Yasemi Street Iranian School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
kheirkhah.m@iums.ac.ir
Web page address
https://fnm.iums.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Failure to disclose information in order to maintain confidentiality
When the data will become available and for how long
Failure to disclose information in order to maintain confidentiality
To whom data/document is available
Failure to disclose information in order to maintain confidentiality
Under which criteria data/document could be used
Failure to disclose information in order to maintain confidentiality
From where data/document is obtainable
Failure to disclose information in order to maintain confidentiality
What processes are involved for a request to access data/document
Failure to disclose information in order to maintain confidentiality
Comments
In the clinical study report section, the report will be submitted to the research system according to the guidance of the university.
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