Clinical trial NCT03308487: Vitamin D Supplementation and Pregnancy Outcomes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Vitamin D Status
Keywords: Vitamin D
pregnancy
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
Collaborators: name: National Nutrition and Food Technology Institute
First posted: 2017-10-12
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: The changes in maternal vitamin D status from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
Secondary outcomes:
measure: The changes in serum concentration of fasting blood glucose from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: The changes in serum concentration of insulin from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: The changes in serum concentration of total cholesterol (TC) from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: The changes in serum concentration of low-density lipoprotein cholesterol (LDL-C) from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: The changes in serum concentration of high-density lipoprotein cholesterol (HDL-C) from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: The changes in serum concentration of triglyceride(TG) from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: The changes in systolic blood pressure from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: The changes in diastolic blood pressure from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: preeclampsia
timeFrame: 2-5 months
measure: Preterm delivery
timeFrame: 5-8 months
measure: Spontaneous abortion
timeFrame: 2-5 months
measure: The changes in cellular secretion of interleukin 1 from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: The changes in cellular secretion of interleukin 6 from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: The changes in cellular secretion of interleukin 10 from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: The changes in cellular secretion of TNF-a from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: The changes in serum concentration of hs-CRP from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: The changes in serum concentration of MDA (Malondialdehyde) from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: The changes in serum concentration of TAC from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: The changes in serum concentration of parathyroid hormone (PTH) from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: The changes in serum concentration of calcium from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: The changes in serum concentration of phosphate from first trimester to last month of pregnancy
timeFrame: baseline and 6-8 months
measure: Apgar score
timeFrame: 6-8 months
measure: The weight measures of newborn
timeFrame: 6-8 months
measure: The height measures of newborn
timeFrame: 6-8 months
measure: The head circumference measures of newborn
timeFrame: 6-8 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
Study officials:
affiliation: National Nutrition and Food Technology Research Institute
name: Tirang R Neyestani, PhD
role: STUDY_CHAIR
References:
citation: 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.