Status:
COMPLETED
Vitamin D Supplementation and Pregnancy Outcomes
Lead Sponsor:
Tirang R. Neyestani, Ph.D.
Collaborating Sponsors:
National Nutrition and Food Technology Institute
Conditions:
Maternal Vitamin D Status
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
Groups (group 1 receives 1000 IU vitamin D and group 2 receives 2000 IU vitamin D) through a random allocation. It is necessary to mention that all cases in each group could be able to receive the cur...
Detailed Description
In this randomized controlled trial, 84 pregnant women aged at 18-40 years with gestational age of \<12 weeks will be recruited and divided into 2 groups. Demographic, socioeconomic and lifestyle dat...
Eligibility Criteria
Inclusion
- maternal age of 18-40 years,
- 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.
Exclusion
- Participants who do not meet the inclusion criteria,
- 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.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03308487
Start Date
January 1 2017
End Date
September 1 2018
Last Update
February 25 2019
Active Locations (1)
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1
National Nutrition and Food Technology Research Institute
Tehran, Iran, 19395-4741