Maternal Vitamin D StatusNCT03308487
Vitamin D Supplementation and Pregnancy Outcomes
A study testing vitamin D3 (1000 IU) and Vitamin D3 (2000 IU) in people with Maternal Vitamin D Status, run by Tirang R. Neyestani, Ph.D. at 1 site in Iran.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Vitamin D Status
- What is being tested?
- vitamin D3 (1000 IU) and Vitamin D3 (2000 IU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteIran
- Study dates
- Jan 2017to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iran1 site
National Nutrition and Food Technology Research Institute
Tehran, 19395-4741
About this study
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
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.
- Conditions
- Maternal Vitamin D Status
- Being tested
- vitamin D3 (1000 IU), Vitamin D3 (2000 IU)
- Keywords
- Vitamin D, pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3 (1000 IU)Dietary supplement
Vitamin D3 (2000 IU)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| vitamin D3 (1000 IU) | Active comparator | group 1 Receives: Dietary Supplement: vitamin D3 (1000 IU) |
| vitamin D3 (2000 IU) | Active comparator | group 2 Receives: Dietary Supplement: Vitamin D3 (2000 IU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The serum concentration of fasting blood glucose will be measured during the first trimester and last month of pregnancy.
Measured: baseline and 6-8 months
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.
Measured: baseline and 6-8 months
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.
Measured: 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
The serum concentration of low-density lipoprotein cholesterol (LDL-C) will be measured during the first trimester and last month of pregnancy.
Measured: 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
The serum concentration of high-density lipoprotein cholesterol (HDL-C) will be measured during the first trimester and last month of pregnancy.
Measured: baseline and 6-8 months
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.
Measured: baseline and 6-8 months
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
Measured: baseline and 6-8 months
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
Measured: baseline and 6-8 months
preeclampsia
Preeclampsia characterized by high blood pressure begins after 20 weeks of pregnancy in women whose blood pressure had been normal.
Measured: 2-5 months
Preterm delivery
A premature birth is a birth that takes place before the start of the 37th week of pregnancy.
Measured: 5-8 months
Spontaneous abortion
Spontaneous abortion is the natural death of an embryo or fetus before 20 weeks of gestation.
Measured: 2-5 months
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.
Measured: baseline and 6-8 months
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.
Measured: baseline and 6-8 months
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.
Measured: baseline and 6-8 months
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.
Measured: baseline and 6-8 months
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.
Measured: baseline and 6-8 months
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.
Measured: baseline and 6-8 months
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.
Measured: baseline and 6-8 months
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.
Measured: baseline and 6-8 months
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.
Measured: baseline and 6-8 months
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.
Measured: baseline and 6-8 months
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.
Measured: 6-8 months
The weight measures of newborn
The data of anthropometric measures including weight will be measured.
Measured: 6-8 months
The height measures of newborn
The data of anthropometric measures including height will be measured.
Measured: 6-8 months
The head circumference measures of newborn
The data of anthropometric measures including head circumference will be measured.
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study startJan 2017
- Primary completionJan 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal Vitamin D StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tirang R. Neyestani, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- National Nutrition and Food Technology Institute
- Responsible party
- Sponsor-investigator, Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Institute
- Investigators
- Tirang R Neyestani, PhD, Study chair, National Nutrition and Food Technology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308487
- Sponsor's protocol ID
- IR.SBMU.RETECH.1395.631
- Status last verified
- Feb 2019
- First submitted
- 13 Jan 2017
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03308487
- Acronym / sponsor ID
- IR.SBMU.RETECH.1395.631
- Conditions
- Maternal Vitamin D Status
- Keywords
- Vitamin D, pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Tirang R. Neyestani, Ph.D.University, hospital or other
- Collaborators
- National Nutrition and Food Technology Institute
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 12 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D3 (1000 IU) | Active comparator | Dietary Supplement: vitamin D3 (1000 IU)group 1 |
| vitamin D3 (2000 IU) | Active comparator | Dietary Supplement: Vitamin D3 (2000 IU)group 2 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D3 (1000 IU) | Dietary supplement | vitamin D3 (1000 IU) |
| Vitamin D3 (2000 IU) | Dietary supplement | vitamin D3 (2000 IU) |
Primary outcome
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.
25 secondary outcomes
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 changes in serum concentration of insulin from first trimester to last month of pregnancy
Time frame: baseline and 6-8 months
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 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 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 changes in serum concentration of triglyceride(TG) from first trimester to last month of pregnancy
Time frame: baseline and 6-8 months
The changes in systolic blood pressure from first trimester to last month of pregnancy
Time frame: baseline and 6-8 months
The changes in diastolic blood pressure from first trimester to last month of pregnancy
Time frame: baseline and 6-8 months
preeclampsia
Time frame: 2-5 months
Preterm delivery
Time frame: 5-8 months
Spontaneous abortion
Time frame: 2-5 months
The changes in cellular secretion of interleukin 1 from first trimester to last month of pregnancy
Time frame: baseline and 6-8 months
The changes in cellular secretion of interleukin 6 from first trimester to last month of pregnancy
Time frame: baseline and 6-8 months
The changes in cellular secretion of interleukin 10 from first trimester to last month of pregnancy
Time frame: baseline and 6-8 months
The changes in cellular secretion of TNF-a from first trimester to last month of pregnancy
Time frame: baseline and 6-8 months
The changes in serum concentration of hs-CRP from first trimester to last month of pregnancy
Time frame: baseline and 6-8 months
The changes in serum concentration of MDA (Malondialdehyde) from first trimester to last month of pregnancy
Time frame: baseline and 6-8 months
The changes in serum concentration of TAC from first trimester to last month of pregnancy
Time frame: baseline and 6-8 months
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 changes in serum concentration of calcium from first trimester to last month of pregnancy
Time frame: baseline and 6-8 months
The changes in serum concentration of phosphate from first trimester to last month of pregnancy
Time frame: baseline and 6-8 months
Apgar score
Time frame: 6-8 months
The weight measures of newborn
Time frame: 6-8 months
The height measures of newborn
Time frame: 6-8 months
The head circumference measures of newborn
Time frame: 6-8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Derived from this study: PubMed 33054794Motamed 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tirang R Neyestani, PhD study chair
National Nutrition and Food Technology Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D3 (1000 IU) and Vitamin D3 (2000 IU) in people with Maternal Vitamin D Status, run by Tirang R. Neyestani, Ph.D. at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in maternal vitamin D status from first trimester to last month of pregnancy (time frame: baseline and 6-8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03308487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.