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Vitamin D Supplementation and Pregnancy Outcomes

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

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.

Condition or disease Intervention/treatment Phase
Maternal Vitamin D Status Dietary Supplement: vitamin D3 (1000 IU) Dietary Supplement: Vitamin D3 (2000 IU) Not Applicable

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, IL-10, 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, IL-10, Tumor Necrosis Factor (TNF-α), hs-CRP) and oxidative stress markers (MDA, TAC) will be determined in cord blood as well.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : January 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. Spontaneous abortion [ Time Frame: 2-5 months ]
    Spontaneous abortion is the natural death of an embryo or fetus before 20 weeks of gestation.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. The weight measures of newborn [ Time Frame: 6-8 months ]
    The data of anthropometric measures including weight will be measured.

  24. The height measures of newborn [ Time Frame: 6-8 months ]
    The data of anthropometric measures including height will be measured.

  25. The head circumference measures of newborn [ Time Frame: 6-8 months ]
    The data of anthropometric measures including head circumference will be measured.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women and their newborns
  • Age: 18-40 years
  • Informed consent
  • Singleton pregnancy

Exclusion Criteria:

  • Multiple pregnancy
  • Diagnosis any kind of diseases including renal, hepatic, and other disorders which could influence vitamin D metabolism during the study, Chronic hypertension
  • Receiving vitamin D or calcium supplements within the last three months, or any medication which could potentially influence vitamin D metabolism (notably estrogens, and calcitonin) within the last three months
  • Newborns with congenital anomalies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308487


Contacts
Contact: Tirang R Neyestani, PhD 00989123507663 neytr@yahoo.com

Locations
Iran, Islamic Republic of
National Nutrition and Food Technology Research Institute Recruiting
Tehran, Iran, Islamic Republic of, 19395-4741
Contact: Tirang R Neyestani, PhD    00989123507663    neytr@yahoo.com   
Sponsors and Collaborators
Tirang R. Neyestani, Ph.D.
National Nutrition and Food Technology Institute
Investigators
Study Chair: Tirang R Neyestani, PhD National Nutrition and Food Technology Research Institute

Responsible Party: Tirang R. Neyestani, Ph.D., Professor (research), National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT03308487     History of Changes
Other Study ID Numbers: IR.SBMU.RETECH.1395.631
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Institute:
Vitamin D
pregnancy

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents