Protocol summary
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Study aim
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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
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Design
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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 .
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Settings and conduct
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This study is a double-blind randomized clinical trial on mothers in Dehkhoda Hospital in Qazvin province.
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Participants/Inclusion and exclusion criteria
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All lactating mothers who have a BMI higher than 25, have no illnesses. They also express that they are breastfeeding their infants.
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Intervention groups
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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).
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Main outcome variables
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Effect of vitamin D supplementation on serum Calcidiol, anthropometric measures and body composition in overweight or obese nursing mothers
General information
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Reason for update
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Unfortunately, in the trial registration some primary and secondary outcomes were written by mistake. So we want to revise them.
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Acronym
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IRCT registration information
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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
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Registration date
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2018-11-04, 1397/08/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-11-06, 1397/08/15
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Expected recruitment end date
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2019-01-10, 1397/10/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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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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Purpose
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Health service research
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 49 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-10-01, 1397/07/09
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Ethics committee reference number
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IR.TUMS.VCR.REC.1397.429
Health conditions studied
1
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Description of health condition studied
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deficiency of vitamin D in lactating women
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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calcidiol
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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KIT
2
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Description
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PTH
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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KIT
3
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Description
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calcium
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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KIT
4
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Description
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phosphore
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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KIT
5
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Description
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Waist Circumference
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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meter-
6
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Description
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Height
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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meter
7
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Description
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weight
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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body impedance analysis Inbody270
8
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Description
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fat mass
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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body impedance analysis Inbody270
9
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Description
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fat free mass
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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body impedance analysis Inbody270
10
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Description
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body fat percentages
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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body impedance analysis Inbody270
11
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Description
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fat mass index
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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body impedance analysis Inbody270
12
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Description
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body mass index
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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body impedance analysis Inbody270
13
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Description
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relative fat mass
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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RFM index for women calculated as 76 − (20 height × WC in meters)
Secondary outcomes
1
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Description
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Assessment of Neonatal Growth(height, head circumference and weight)
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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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
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Description
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frequency of visiting a doctor
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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doctor
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
3
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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80
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available