Clinical trial of the effect of zinc supplementation compared with the placebo on metabolic profiles in pregnant women at risk for intrauterine growth restriction
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: unwillingness to cooperate
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:2018-06-03, 1397/03/13
Update count:1
Registration date
2018-06-03, 1397/03/13
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
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:
Exclusion criteria: Unwillingness to cooperate
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 and after stratification for pre-intervention BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y), subjects will be randomly 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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
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