Vitamin D Supplementation and Pregnancy Outcomes

• ClinicalTrials.gov Identifier: NCT03308487
• Recruitment Status: Completed
• First Posted: October 12, 2017
• Last Update Posted: February 25, 2019
• Sponsor: Tirang R. Neyestani, Ph.D.
• Collaborator: National Nutrition and Food Technology Institute
• Information provided by (Responsible Party): Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Institute

Tracking Information

• First Submitted Date: January 13, 2017
• First Posted Date: October 12, 2017
• Last Update Posted Date: February 25, 2019
• Actual Study Start Date: January 2017
• Actual Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 7, 2017)

The changes in maternal vitamin D status from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]

The serum concentration of 25(OH) D will be measured during the first trimester and last month of pregnancy.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 7, 2017)

• The changes in serum concentration of fasting blood glucose from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  The serum concentration of fasting blood glucose will be measured during the first trimester and last month of pregnancy.
• The changes in serum concentration of insulin from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  The serum concentration of insulin will be measured during the first trimester and last month of pregnancy.
• The changes in serum concentration of total cholesterol (TC) from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  The serum concentration of total cholesterol (TC) will be measured during the first trimester and last month of pregnancy.
• The changes in serum concentration of low-density lipoprotein cholesterol (LDL-C) from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  The serum concentration of low-density lipoprotein cholesterol (LDL-C) will be measured during the first trimester and last month of pregnancy.
• The changes in serum concentration of high-density lipoprotein cholesterol (HDL-C) from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  The serum concentration of high-density lipoprotein cholesterol (HDL-C) will be measured during the first trimester and last month of pregnancy.
• The changes in serum concentration of triglyceride(TG) from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  The serum concentration of triglyceride(TG) will be measured during the first trimester and last month of pregnancy.
• The changes in systolic blood pressure from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  systolic and diastolic blood pressure will be measured by a training physician
• The changes in diastolic blood pressure from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  systolic and diastolic blood pressure will be measured by a training physician
• preeclampsia [ Time Frame: 2-5 months ]
  Preeclampsia characterized by high blood pressure begins after 20 weeks of pregnancy in women whose blood pressure had been normal.
• Preterm delivery [ Time Frame: 5-8 months ]
  A premature birth is a birth that takes place before the start of the 37th week of pregnancy.
• Spontaneous abortion [ Time Frame: 2-5 months ]
  Spontaneous abortion is the natural death of an embryo or fetus before 20 weeks of gestation.
• The changes in cellular secretion of interleukin 1 from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  The status of interleukin 1 will be measured during the first trimester and last month of pregnancy.
• The changes in cellular secretion of interleukin 6 from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  The status of interleukin 6 will be measured during the first trimester and last month of pregnancy.
• The changes in cellular secretion of interleukin 10 from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  The status of interleukin 10 will be measured during the first trimester and last month of pregnancy.
• The changes in cellular secretion of TNF-a from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  The status of TNF-a will be measured during the first trimester and last month of pregnancy.
• The changes in serum concentration of hs-CRP from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  The status of hs-CRP will be measured during the first trimester and last month of pregnancy.
• The changes in serum concentration of MDA (Malondialdehyde) from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  the serum concentration of MDA (Malondialdehyde) will be measured during the first trimester and last month of pregnancy.
• The changes in serum concentration of TAC from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  the serum concentration of TAC will be measured during the first trimester and last month of pregnancy.
• The changes in serum concentration of parathyroid hormone (PTH) from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  the serum concentration of parathyroid hormone (PTH) will be measured during the first trimester and last month of pregnancy.
• The changes in serum concentration of calcium from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  the serum concentration of calcium will be measured during the first trimester and last month of pregnancy.
• The changes in serum concentration of phosphate from first trimester to last month of pregnancy [ Time Frame: baseline and 6-8 months ]
  the serum concentration of phosphate will be measured during the first trimester and last month of pregnancy.
• Apgar score [ Time Frame: 6-8 months ]
  The Apgar score is a quick evaluation of one minute and five minutes after birth which tests the birthing process and readiness of newborn to meet the world without additional medical assistance.
• The weight measures of newborn [ Time Frame: 6-8 months ]
  The data of anthropometric measures including weight will be measured.
• The height measures of newborn [ Time Frame: 6-8 months ]
  The data of anthropometric measures including height will be measured.
• The head circumference measures of newborn [ Time Frame: 6-8 months ]
  The data of anthropometric measures including head circumference will be measured.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Maternal Vitamin D Status

Intervention

• Dietary Supplement: vitamin D3 (1000 IU)
• Dietary Supplement: Vitamin D3 (2000 IU)

Study Arms

• Active Comparator: vitamin D3 (1000 IU)
  group 1
  Intervention: Dietary Supplement: vitamin D3 (1000 IU)
• Active Comparator: vitamin D3 (2000 IU)
  group 2
  Intervention: Dietary Supplement: Vitamin D3 (2000 IU)

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 7, 2017): 84
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 2018
• Actual Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Iran, Islamic Republic of

Administrative Information

• NCT Number: NCT03308487
• Other Study ID Numbers: IR.SBMU.RETECH.1395.631
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Institute
• Study Sponsor: Tirang R. Neyestani, Ph.D.
• Collaborators: National Nutrition and Food Technology Institute

Investigators

• Study Chair: Tirang R Neyestani, PhD; National Nutrition and Food Technology Research Institute

• PRS Account: National Nutrition and Food Technology Institute
• Verification Date: February 2019