Vitamin D Supplementation and Pregnancy Outcomes

NCT03308487 | Completed DMC

• 1 other identifier: IR.SBMU.RETECH.1395.631
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Vitamin D Status

Keywords

Vitamin D; pregnancy

Outcome Measures

Primary Outcomes (1)

• The changes in maternal vitamin D status from first trimester to last month of pregnancy

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

  baseline and 6-8 months

Secondary Outcomes (25)

• The changes in serum concentration of fasting blood glucose from first trimester to last month of pregnancy

  baseline and 6-8 months

• The changes in serum concentration of insulin from first trimester to last month of pregnancy

  baseline and 6-8 months

• The changes in serum concentration of total cholesterol (TC) from first trimester to last month of pregnancy

  baseline and 6-8 months

• The changes in serum concentration of low-density lipoprotein cholesterol (LDL-C) from first trimester to last month of pregnancy

  baseline and 6-8 months

• The changes in serum concentration of high-density lipoprotein cholesterol (HDL-C) from first trimester to last month of pregnancy

  baseline and 6-8 months

Study Arms (2)

vitamin D3 (1000 IU)

ACTIVE COMPARATOR

group 1

Dietary Supplement: vitamin D3 (1000 IU)

vitamin D3 (2000 IU)

ACTIVE COMPARATOR

group 2

Dietary Supplement: Vitamin D3 (2000 IU)

Interventions

vitamin D3 (1000 IU) DIETARY_SUPPLEMENT

vitamin D3 (1000 IU)

Vitamin D3 (2000 IU) DIETARY_SUPPLEMENT

vitamin D3 (2000 IU)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tirang R. Neyestani, Ph.D.: lead
• National Nutrition and Food Technology Institute: collaborator

Study Sites (1)

National Nutrition and Food Technology Research Institute

Tehran, 19395-4741, Iran

Location

Related Publications (1)

• 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.

  PMID: 33054794 DERIVED

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Tirang R Neyestani, PhD

  National Nutrition and Food Technology Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor (research)

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: October 12, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)