Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2017-01-31
2018-09-30
Brief Summary
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Detailed Description
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Demographic, socioeconomic and lifestyle data as well as blood samples and urine samples will be collected at baseline and in the last month of pregnancy. Moreover the cord blood will be collected at birth.
Fasting blood glucose, insulin resistance (HOMA-IR), insulin, lipid profile (serum concentration of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglyceride(TG)), inflammatory (IL-1β, IL-6, TNF-α, hs-CRP) and oxidative stress markers (MDA, TAC), calcium:creatinine ratio are going to be evaluated at the beginning and in the end of the interventional period in pregnant women. Inflammatory (IL-1β, IL-6, Tumor Necrosis Factor (TNF-α), hs-CRP) and oxidative stress markers (MDA, TAC) will be determined in cord blood as well.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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vitamin D3 (1000 IU)
group 1
vitamin D3 (1000 IU)
vitamin D3 (2000 IU)
group 2
Vitamin D3 (2000 IU)
Interventions
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vitamin D3 (1000 IU)
Vitamin D3 (2000 IU)
Eligibility Criteria
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Inclusion Criteria
* gestational age of 12 weeks or less,
* singleton pregnancies,
* mothers supposed to have normal pregnancy and not having preexisting diseases like hypertension, or cardiac, renal, hepatic, autoimmune , rheumatoid arthritis and digestive disease, or endocrinological disorders including diabetes (type 1 or type 2 diabetes), parathyroid disorders, and thyroid disorder,
* not receiving dietary supplements including vitamin D (\>600 IU/d), or omega-3 within the past 3 months before the intervention,
* not taking medications that could potentially influence vitamin D metabolism,
* willingness to participate in the study.
* those who diagnosed to have fasting blood sugar (FBS)\>92 at first blood sampling and/or blood pressure \> 140/90 mmHg at the first visit,
* using extra vitamin D3 supplement and/or omega-3 and/or other medications that could potentially influence vitamin D metabolism,
* fetal anomaly,
* poor adherence to the study protocol,
* unwillingness to continue the intervention.
18 Years
40 Years
FEMALE
Yes
Sponsors
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National Nutrition and Food Technology Institute
OTHER
Tirang R. Neyestani, Ph.D.
OTHER
Responsible Party
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Tirang R. Neyestani, Ph.D.
Professor (research)
Principal Investigators
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Tirang R Neyestani, PhD
Role: STUDY_CHAIR
National Nutrition and Food Technology Research Institute
Locations
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National Nutrition and Food Technology Research Institute
Tehran, , Iran
Countries
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References
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Motamed S, Nikooyeh B, Kashanian M, Chamani M, Hollis BW, Neyestani TR. Evaluation of the efficacy of two doses of vitamin D supplementation on glycemic, lipidemic and oxidative stress biomarkers during pregnancy: a randomized clinical trial. BMC Pregnancy Childbirth. 2020 Oct 14;20(1):619. doi: 10.1186/s12884-020-03311-1.
Other Identifiers
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IR.SBMU.RETECH.1395.631
Identifier Type: -
Identifier Source: org_study_id
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