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Vitamin D DeficiencyDMATNCT02506439

Nutritional Requirements for Vitamin D in Pregnant Women

A study testing 10 mcg Vitamin D3 and 20 mcg Vitamin D3 in people with Vitamin D Deficiency, run by University College Cork at 2 sites in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Randomised, placebo-controlled dose-response intervention study with vitamin D3 in pregnant women. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Vitamin D Deficiency
What is being tested?
10 mcg Vitamin D3 and 20 mcg Vitamin D3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
144 participants
Where
2 sitesIreland
Study dates
1 Nov 2014to 1 Apr 2017
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult (>18 years)
  • No more than 18 weeks gestation
  • In good general health
  • Low risk pregnancy
  • Not consuming >10 mcg/d vitamin D from supplements

Who cannot join

  • Current smokers
  • Diagnosed hypertension
  • Known high-risk pregnancy
  • Diagnosed medical illness including diabetes mellitus (Types 1 \& 2), chronic kidney disease or gastro-intestinal diseases or any illness known to interfere with calcium metabolism (e.g. sarcoidosis).
  • Consumption of medications known to interfere with vitamin D metabolism
  • Consumption of vitamin D (≥ 10 µg/day) or calcium (≥ 650 mg/d) supplements prior to randomization

Trial locations and contacts

2 sites in 1 country.

Ireland2 sites

  • Cork University Maternity Hospital and University College Cork

    Cork

  • Human Nutrition Resource Unit, School of Food and Nutritional Sciences, University College Cork

    Cork

Other trials in Ireland

About this study

Official title: Randomized Controlled Trial to Determine the Nutritional Requirement for Vitamin D for Prevention of Deficiency During Pregnancy and in the Early Neonatal Period (D-MAT)

Randomised, placebo-controlled dose-response intervention study with vitamin D3 in pregnant women.

Read the detailed description

This is a three-arm, parallel, double-blind, placebo-controlled dose-response intervention study with vitamin D3. Women will be recruited prior to 18 weeks of gestation and randomised to receive placebo, 10 or 20 mcg/d of vitamin D3 from baseline visit in their first trimester until delivery. Blood samples will be collected at baseline, midpoint and endpoint of the trial, at 10 week intervals, and from the umbilical cord at delivery. A 25-hydroxyvitamin D concentration of 30 nmol/L will be used to denote vitamin D deficiency. Information on maternal anthropometry, diet, lifestyle, sun exposure, blood pressure, iPTH and serum total calcium will also be reported.

Being tested
10 mcg Vitamin D3, 20 mcg Vitamin D3, Placebo
Keywords
Vitamin D, Cholecalciferol, Dose-response, Randomized Controlled Trial, Pregnancy, Cord blood, Serum 25-hydroxyvitamin D, Vitamin D Deficiency, Nutrition, Dietary intervention study
Medical subject headings
Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 10 mcg Vitamin D3Dietary supplement

    Also called Cholecalciferol

    Once daily, 10mcg (400IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)

  • 20 mcg Vitamin D3Dietary supplement

    Also called Cholecalciferol

    Once daily, 20mcg (800IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)

  • PlaceboDietary supplement

    Also called Placebo capsule

    Once daily, placebo capsule containing 0mcg (0IU) of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)

Study groups in NCT02506439
Study groupRoleWhat they receive
10 mcg Vitamin D3ExperimentalWhite-skinned women will receive Cholecalciferol (Vitamin D3) 10 mcg [400 IU] daily
Receives: Dietary Supplement: 10 mcg Vitamin D3
20 mcg Vitamin D3ExperimentalWhite-skinned women will receive Cholecalciferol (Vitamin D3) 20 mcg [800 IU] daily
Receives: Dietary Supplement: 20 mcg Vitamin D3
PlaceboPlacebo comparatorWhite-skinned women will receive a Placebo supplement, identical in appearance and taste to the active product
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum 25-hydroxyvitamin D in pregnant women and cord blood

    Analysis of serum 25-hydroxyvitamin D in mothers for blood taken in the first, second and third trimesters and in umbilical cord

    Measured: Change from 1st through 2nd trimester and at delivery

Secondary outcomes (2)

  1. Serum total calcium

    Analysis of serum total calcium (adjusted for albumin) in mothers for blood taken in the first, second and third trimesters and in umbilical cord

    Measured: Change from 1st through 2nd trimester and at delivery

  2. Serum Parathyroid Hormone

    Analysis of serum PTH in mothers for blood taken in the first, second and third trimesters and in umbilical cord

    Measured: Change from 1st through 2nd trimester and at delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2015 (estimated)
  2. Study start1 Nov 2014
  3. Primary completion1 Apr 2017
  4. Study completion1 Apr 2017

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02506439
Sponsor's protocol ID
ODINWP4DMAT
Acronym
DMAT
Status last verified
Nov 2024
First submitted
12 May 2015
Last updated
19 Nov 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided: IPD may be considered, for vitamin D intake and 25(OH)D data. Please contact m.kiely@ucc.ie.

Publications

  • Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.

    PubMed 39077939

  • O'Callaghan KM, Hennessy A, Hull GLJ, Healy K, Ritz C, Kenny LC, Cashman KD, Kiely ME. Estimation of the maternal vitamin D intake that maintains circulating 25-hydroxyvitamin D in late gestation at a concentration sufficient to keep umbilical cord sera >/=25-30 nmol/L: a dose-response, double-blind, randomized placebo-controlled trial in pregnant women at northern latitude. Am J Clin Nutr. 2018 Jul 1;108(1):77-91. doi: 10.1093/ajcn/nqy064.

    PubMed 29878035

Questions about this trial

What is this clinical trial studying?

A study testing 10 mcg Vitamin D3 and 20 mcg Vitamin D3 in people with Vitamin D Deficiency, run by University College Cork at 2 sites in Ireland.

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 5 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 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Ireland. 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. Some participants in this study may receive a placebo. 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?

Serum 25-hydroxyvitamin D in pregnant women and cord blood (time frame: Change from 1st through 2nd trimester and at delivery). 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 NCT02506439, which also lists 2 linked publications.

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 19 Nov 2024.

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