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CompletedNCT03308487Updated Feb 25, 2019

Vitamin D Supplementation and Pregnancy Outcomes

An interventional study of vitamin D3 (1000 IU) and Vitamin D3 (2000 IU) in Maternal Vitamin D Status, sponsored by Tirang R. Neyestani, Ph.D.. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-25.

Sponsored by Tirang R. Neyestani, Ph.D. · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Maternal Vitamin D Status

Keywords

  • Vitamin D
  • pregnancy
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
84 participants (actual)

Study arms

  • Active comparator
    vitamin D3 (1000 IU)

    group 1

    Dietary Supplement: vitamin D3 (1000 IU)

  • Active comparator
    vitamin D3 (2000 IU)

    group 2

    Dietary Supplement: Vitamin D3 (2000 IU)

Interventions

  • Dietary supplementvitamin D3 (1000 IU)
  • Dietary supplementVitamin D3 (2000 IU)
05

What researchers measure

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.

    Time frame: baseline and 6-8 months

Secondary outcomes

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

    The serum concentration of fasting blood glucose will be measured during the first trimester and last month of pregnancy.

    Time frame: baseline and 6-8 months

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

    The serum concentration of insulin will be measured during the first trimester and last month of pregnancy.

    Time frame: baseline and 6-8 months

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

    The serum concentration of total cholesterol (TC) will be measured during the first trimester and last month of pregnancy.

    Time frame: baseline and 6-8 months

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

    The serum concentration of low-density lipoprotein cholesterol (LDL-C) will be measured during the first trimester and last month of pregnancy.

    Time frame: baseline and 6-8 months

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

    The serum concentration of high-density lipoprotein cholesterol (HDL-C) will be measured during the first trimester and last month of pregnancy.

    Time frame: baseline and 6-8 months

  6. The changes in serum concentration of triglyceride(TG) from first trimester to last month of pregnancy

    The serum concentration of triglyceride(TG) will be measured during the first trimester and last month of pregnancy.

    Time frame: baseline and 6-8 months

  7. The changes in systolic blood pressure from first trimester to last month of pregnancy

    systolic and diastolic blood pressure will be measured by a training physician

    Time frame: baseline and 6-8 months

  8. The changes in diastolic blood pressure from first trimester to last month of pregnancy

    systolic and diastolic blood pressure will be measured by a training physician

    Time frame: baseline and 6-8 months

  9. preeclampsia

    Preeclampsia characterized by high blood pressure begins after 20 weeks of pregnancy in women whose blood pressure had been normal.

    Time frame: 2-5 months

  10. Preterm delivery

    A premature birth is a birth that takes place before the start of the 37th week of pregnancy.

    Time frame: 5-8 months

  11. Spontaneous abortion

    Spontaneous abortion is the natural death of an embryo or fetus before 20 weeks of gestation.

    Time frame: 2-5 months

  12. The changes in cellular secretion of interleukin 1 from first trimester to last month of pregnancy

    The status of interleukin 1 will be measured during the first trimester and last month of pregnancy.

    Time frame: baseline and 6-8 months

  13. The changes in cellular secretion of interleukin 6 from first trimester to last month of pregnancy

    The status of interleukin 6 will be measured during the first trimester and last month of pregnancy.

    Time frame: baseline and 6-8 months

  14. The changes in cellular secretion of interleukin 10 from first trimester to last month of pregnancy

    The status of interleukin 10 will be measured during the first trimester and last month of pregnancy.

    Time frame: baseline and 6-8 months

  15. The changes in cellular secretion of TNF-a from first trimester to last month of pregnancy

    The status of TNF-a will be measured during the first trimester and last month of pregnancy.

    Time frame: baseline and 6-8 months

  16. The changes in serum concentration of hs-CRP from first trimester to last month of pregnancy

    The status of hs-CRP will be measured during the first trimester and last month of pregnancy.

    Time frame: baseline and 6-8 months

  17. The changes in serum concentration of MDA (Malondialdehyde) from first trimester to last month of pregnancy

    the serum concentration of MDA (Malondialdehyde) will be measured during the first trimester and last month of pregnancy.

    Time frame: baseline and 6-8 months

  18. The changes in serum concentration of TAC from first trimester to last month of pregnancy

    the serum concentration of TAC will be measured during the first trimester and last month of pregnancy.

    Time frame: baseline and 6-8 months

  19. The changes in serum concentration of parathyroid hormone (PTH) from first trimester to last month of pregnancy

    the serum concentration of parathyroid hormone (PTH) will be measured during the first trimester and last month of pregnancy.

    Time frame: baseline and 6-8 months

  20. The changes in serum concentration of calcium from first trimester to last month of pregnancy

    the serum concentration of calcium will be measured during the first trimester and last month of pregnancy.

    Time frame: baseline and 6-8 months

  21. The changes in serum concentration of phosphate from first trimester to last month of pregnancy

    the serum concentration of phosphate will be measured during the first trimester and last month of pregnancy.

    Time frame: baseline and 6-8 months

  22. Apgar score

    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.

    Time frame: 6-8 months

  23. The weight measures of newborn

    The data of anthropometric measures including weight will be measured.

    Time frame: 6-8 months

  24. The height measures of newborn

    The data of anthropometric measures including height will be measured.

    Time frame: 6-8 months

  25. The head circumference measures of newborn

    The data of anthropometric measures including head circumference will be measured.

    Time frame: 6-8 months

06

Study locations

1 site
  • National Nutrition and Food Technology Research Institute
    Tehran, 19395-4741, Iran, Islamic Republic of
07

References and documents

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. PubMed 33054794 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03308487
Lead sponsor
Tirang R. Neyestani, Ph.D.
Collaborators
National Nutrition and Food Technology Institute
Responsible party
Tirang R. Neyestani, Ph.D. (Professor (research), National Nutrition and Food Technology Institute) — Sponsor-investigator
First posted
Oct 12, 2017
Start date
Jan 2017
Primary completion
Jan 2018
Completion
Sep 2018
Last update
Feb 25, 2019

Study contacts

Tirang R Neyestani, PhD
study chair · National Nutrition and Food Technology Research Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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