Protocol summary
-
Study aim
-
The aim of this study is to determine the effects of zinc supplementation on metabolic profiles in pregnant women at risk for intrauterine growth restriction
-
Design
-
Design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive zinc supplements (n=30) or placebo (n=30).
-
Settings and conduct
-
Among pregnant women at risk for intrauterine growth restriction referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 10 weeks after the intervention. At the beginning and the end of the intervention: 10 weeks
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Pregnant women at risk for intrauterine growth restriction, aged 18 to 40 years. Exclusion criterion: The consumption of zinc supplements throughout past 3 months, hyper- and hypothyroidism, urinary tract infection, smoking and also having liver or kidney diseases.
-
Intervention groups
-
Intervention group: zinc supplements, 100 µg, daily, for 10 weeks orally. Control group: Placebo once a day for 10 weeks orally.
-
Main outcome variables
-
Total Antioxidant Capacity and Pulsatility Index (primary outcomes) and lipid profiles, markers of insulin metabolism and inflammatory factors (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20170513033941N33
Registration date:
2018-06-03, 1397/03/13
Registration timing:
retrospective
Last update:
2019-09-24, 1398/07/02
Update count:
1
-
Registration date
-
2018-06-03, 1397/03/13
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2018-03-06, 1396/12/15
-
Expected recruitment end date
-
2018-04-04, 1397/01/15
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Clinical trial of the effect of zinc supplementation compared with the placebo on metabolic profiles in pregnant women at risk for intrauterine growth restriction
-
Public title
-
Effect of zinc supplementation in treatment of pregnant women at risk for intrauterine growth restriction
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Inclusion criteria: Pregnant women at risk for intrauterine growth restriction.
Individuals aged 18 to 40 years.
Exclusion criteria:
The consumption of zinc supplements throughout past 3 months
Hyper- and hypothyroidism
Urinary tract infection
Smoking
Having liver or kidney diseases
-
Age
-
From 18 years old to 40 years old
-
Gender
-
Female
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
60
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
At study baseline, after balanced randomisation, subjects will be divided into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2018-03-05, 1396/12/14
-
Ethics committee reference number
-
IR.KAUMS.MEDNT.REC.1396.117
Health conditions studied
1
-
Description of health condition studied
-
Pregnancy
-
ICD-10 code
-
094
-
ICD-10 code description
-
Sequelae of complication of pregnancy, childbirth and the puerperium
Primary outcomes
1
-
Description
-
Total antioxidant
-
Timepoint
-
At the beginning of the study and after 10 weeks of intervention
-
Method of measurement
-
Spectrophotometry
2
-
Description
-
pulsatility index
-
Timepoint
-
At the beginning of the study and after 10 weeks of intervention
-
Method of measurement
-
Sonography
Secondary outcomes
1
-
Description
-
Insulin
-
Timepoint
-
At the beginning of the study and after 10 weeks of intervention
-
Method of measurement
-
Elisa kit
2
-
Description
-
hs-CRP
-
Timepoint
-
At the beginning of the study and after 10 weeks of intervention
-
Method of measurement
-
Elisa kit
3
-
Description
-
Nitric oxide
-
Timepoint
-
At the beginning of the study and after 10 weeks of intervention
-
Method of measurement
-
Spectrophotometry
4
-
Description
-
Triglycerides
-
Timepoint
-
At the beginning of the study and after 10 weeks of intervention
-
Method of measurement
-
Enzymatic kit
5
-
Description
-
Cholesterol
-
Timepoint
-
At the beginning of the study and after 10 weeks of intervention
-
Method of measurement
-
Enzymatic kit
6
-
Description
-
Glutathione
-
Timepoint
-
At the beginning of the study and after 10 weeks of intervention
-
Method of measurement
-
Spectrophotometry
7
-
Description
-
Malondialdehyde
-
Timepoint
-
At the beginning of the study and after 10 weeks of intervention
-
Method of measurement
-
Spectrophotometry
8
-
Description
-
HDL-cholesterol
-
Timepoint
-
At the beginning of the study and after 10 weeks of intervention
-
Method of measurement
-
Enzymatic kit
Intervention groups
1
-
Description
-
Intervention group: zinc supplement, 100 µg, daily, for 10 weeks orally
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Placebo, daily, for 10 weeks orally.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Kashan 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
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