NCT03308487

Vitamin D Supplementation and Pregnancy Outcomes

Evaluation and Comparison of the Efficacy of 1000 and 2000 IU/d Vitamin D Supplementation During Pregnancy on Maternal and Newborn Vitamin D Status and Pregnancy Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Tirang R. Neyestani, Ph.D. · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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 current supplementation during pregnancy (Folic acid, iron and multivitamin and calcium). This study aimed to evaluate the efficacy of two doses of vitamin D supplementation (1000 and 2000 IU/d) during pregnancy on maternal and newborn vitamin D status and metabolic profile including lipid profile (serum concentration of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglyceride(TG)), glucose homeostasis (fasting glucose, insulin, insulin resistance (HOMA-IR)) and inflammatory and oxidative stress (OS) markers and pregnancy outcomes including gestational diabetes, preeclampsia, preterm delivery, abortion, cesarian section, and also anthropometric data and apgar score of infants compared with placebo.

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 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

• Maternal Vitamin D Status

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	vitamin D3 (1000 IU)
DIETARY_SUPPLEMENT	Vitamin D3 (2000 IU)

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-01-01
• Completion: 2018-09-01
• First posted: 2017-10-12
• Last updated: 2019-02-25

Locations

1 site across 1 country: Iran