ObesityMO-VITDNCT02713009

Impact of Maternal Body Weight on Vitamin D Status During Pregnancy

A study testing Pregnancy multi-vitamin (including 10μg vitamin D3) and 10μg vitamin D3 in people with Obesity and Vitamin D Deficiency, run by University of Ulster at 1 site in United Kingdom.

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

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Obesity, Vitamin D Deficiency
What is being tested?: Pregnancy multi-vitamin (including 10μg vitamin D3) and 10μg vitamin D3
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 240 participants
Where: 1 siteUnited Kingdom
Study dates: Nov 2015to Mar 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 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Pregnant women
Age ≥18years
BMI >18.5 kg/m²
Without current pregnancy related complications
At least 12 weeks gestation
Have a singleton pregnancy (as confirmed at first scan)
Pregnant women who are currently taking vitamin D and have had a sun holiday will be included in this study. All participants will agree to discontinue any current supplementation and will be provided with a multivitamin for the duration of pregnancy.

Who cannot join

Aged <18 years
Pregnancy BMI <18.5kg/m²
Participants with multiple pregnancy
Participants currently involved in another research study
Participants with a history of gastrointestinal, hepatic, renal, vascular or haematological disorders.
Participants who have had in vitro fertilisation (IVF) treatment

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Participants with a history of NTD affected pregnancies
Pregnant women with active thyroid disease (e.g., Graves, Hashimoto or thyroiditis)
Planned home births

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Western Health and Social Care Trust, Altnagelvin
Londonderry, Co.Londonderry

Other trials in United Kingdom

About this study

Official title: Investigation of the Impact of Maternal Body Weight on Vitamin D Status During Pregnancy: a Randomised Supplementation Study

Research shows high levels of vitamin D deficiency in pregnant women in Northern Ireland. Body composition is a determinant of vitamin D status. Vitamin D is a fat soluble vitamin and therefore may be hidden within the adipose/fat tissue in overweight/obese individuals. All pregnant and breastfeeding women are advised to take a daily supplement containing 10μg vitamin D. The investigators hypothesise that overweight/ obese pregnant women have a lower vitamin D status than their leaner counterparts at the start of pregnancy and may need a higher daily supplementation to achieve a sufficient status.

The investigators propose a randomised supplementation study where pregnant women (n 240) from the Western Health and Social Care Trust Area will be invited to take part.

Inclusion criteria: pregnant women first trimester, without current pregnancy related complications, singleton pregnancy, aged ≥18 years, with Body Mass Index (BMI) > 18.5kg /m².

Participants will be randomised to receive either 0μg (placebo) plus a multivitamin or 10μg vitamin D plus a multivitamin from 12 weeks gestation until delivery. The multivitamin already contains 10μg vitamin D; Therefore participants will be randomised to receive a total of 10μg or 20μg vitamin D.

Blood samples (20mls) will be taken at 12, 28 and 36 weeks gestation. A sample of blood will be taken from the cord after delivery. Vitamin D status is the main outcome measurement. All blood samples will be analysed for vitamin D and other associated metabolites. Data will be collected on health and lifestyle, supplementation use and food intake. Body composition measurements will be recorded at each appointment and infant anthropometric measurements will be taken from the maternal notes after delivery. Findings from this research will be used to inform nutrition policy on appropriate vitamin D supplementation levels in pregnancy which may be dependent upon pre pregnancy BMI.

Conditions: Obesity, Vitamin D Deficiency
Being tested: Pregnancy multi-vitamin (including 10μg vitamin D3), 10μg vitamin D3, 0μg vitamin D (placebo)
Keywords: Maternal body weight, Vitamin D, Pregnancy
Medical subject headings: Obesity, Vitamin D Deficiency

What participants receive

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

Pregnancy multi-vitamin (including 10μg vitamin D3)Dietary supplement
10μg vitamin D3Dietary supplement
0μg vitamin D (placebo)Dietary supplement

Study groups in NCT02713009
Study group	Role	What they receive
Treatment 1	Experimental	Pregnancy multivitamin + vitamin D daily from ~Week 12 gestation until delivery Receives: Dietary Supplement: Pregnancy multi-vitamin (including 10μg vitamin D3); Dietary Supplement: 10μg vitamin D3
Treatment 2	Placebo comparator	Pregnancy multivitamin + placebo daily from ~Week 12 gestation until delivery Receives: Dietary Supplement: Pregnancy multi-vitamin (including 10μg vitamin D3); Dietary Supplement: 0μg vitamin D (placebo)

What is being measured

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

Change in Vitamin D (25-hydroxyvitamin D) status
Serum Vitamin D status (Week 12, 28 + 36 gestation) \& cord serum Vitamin D status (delivery)
Measured: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)

Secondary outcomes (14)

Gestational weight gain
Measured: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation)
Change in inflammation status
Plasma inflammation status (Week 12, 28 + 36 gestation) \& cord plasma inflammation status (delivery)
Measured: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Change in bone turnover markers
Plasma bone turnover markers (Week 12, 28 + 36 gestation) \& cord plasma bone turnover markers (delivery)
Measured: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Genetics
e.g. CYP2R1, CYP27B1, CYP24A1
Measured: Baseline (Week 12 gestation)
Dietary intake
Food diary with food frequency questionnaire
Measured: Week 28 gestation
Foetal growth chart measurement
Measured: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Change in Vitamin D related measures
Blood Vitamin D related status (Week 12, 28 + 36 gestation) \& cord Vitamin D related status (delivery)
Measured: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Haemoglobin
As part of full blood count
Measured: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Plasma ferritin
Clinical chemistry analyser
Measured: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Transferrin saturation
Clinical chemistry analyser
Measured: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Iron status
Serum, clinical chemistry analyser
Measured: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Soluble transferrin receptor
ELISA
Measured: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Hepcidion
ELISA
Measured: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Methylation analysis
Iron and vitamin D related genes
Measured: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)

Timeline

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

Nov 2015Mar 2018

First posted18 Mar 2016 (estimated)
Study startNov 2015
Primary completionMar 2018
Study completionMar 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 ObesityStudies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02713009
Sponsor's protocol ID: REC 15/NI/0068
Acronym: MO-VITD
Status last verified: Feb 2023
First submitted: 14 Jan 2016
Last updated: 3 Mar 2023
Results posted: No
Data monitoring committee: No

Publications

Alhomaid RM, Mulhern MS, Strain J, Laird E, Healy M, Parker MJ, McCann MT. Maternal obesity and baseline vitamin D insufficiency alter the response to vitamin D supplementation: a double-blind, randomized trial in pregnant women. Am J Clin Nutr. 2021 Sep 1;114(3):1208-1218. doi: 10.1093/ajcn/nqab112.
PubMed 33964855

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Impact of Maternal Body Weight on Vitamin D Status During Pregnancy: a Randomised Supplementation Study
ClinicalTrials.gov ID: NCT02713009
Acronym / sponsor ID: MO-VITD / REC 15/NI/0068
Conditions: Obesity, Vitamin D Deficiency
Keywords: Maternal body weight, Vitamin D, Pregnancy
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: University of UlsterUniversity, hospital or other
Collaborators: Western Health and Social Care Trust
Study start: Nov 2015 (actual)
Primary completion: Mar 2018 (actual)
Study completion: Mar 2018 (actual)
First posted: 18 Mar 2016 (estimated)
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.

The investigators propose a randomised supplementation study where pregnant women (n 240) from the Western Health and Social Care Trust Area will be invited to take part.

Inclusion criteria: pregnant women first trimester, without current pregnancy related complications, singleton pregnancy, aged ≥18 years, with Body Mass Index (BMI) > 18.5kg /m².

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Treatment 1	Experimental	Dietary Supplement: Pregnancy multi-vitamin (including 10μg vitamin D3), Dietary Supplement: 10μg vitamin D3Pregnancy multivitamin + vitamin D daily from ~Week 12 gestation until delivery
Treatment 2	Placebo comparator	Dietary Supplement: Pregnancy multi-vitamin (including 10μg vitamin D3), Dietary Supplement: 0μg vitamin D (placebo)Pregnancy multivitamin + placebo daily from ~Week 12 gestation until delivery

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Pregnant women
Age ≥18years
BMI >18.5 kg/m²
Without current pregnancy related complications
At least 12 weeks gestation

Key exclusion criteria (9 listed)

Aged <18 years
Pregnancy BMI <18.5kg/m²
Participants with multiple pregnancy
Participants currently involved in another research study
Participants with a history of gastrointestinal, hepatic, renal, vascular or haematological disorders.

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
Pregnancy multi-vitamin (including 10μg vitamin D3)	Dietary supplement	Treatment 1, Treatment 2
10μg vitamin D3	Dietary supplement	Treatment 1
0μg vitamin D (placebo)	Dietary supplement	Treatment 2

Primary outcome

Change in Vitamin D (25-hydroxyvitamin D) status
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Serum Vitamin D status (Week 12, 28 + 36 gestation) \& cord serum Vitamin D status (delivery)

14 secondary outcomes

Gestational weight gain
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation)
Change in inflammation status
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Change in bone turnover markers
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Genetics
Time frame: Baseline (Week 12 gestation)
Dietary intake
Time frame: Week 28 gestation
Foetal growth chart measurement
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Change in Vitamin D related measures
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Haemoglobin
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Plasma ferritin
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Transferrin saturation
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Iron status
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Soluble transferrin receptor
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Hepcidion
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Methylation analysis
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)

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 3 Mar 2023.
Derived from this study: PubMed 33964855Alhomaid RM, Mulhern MS, Strain J, Laird E, Healy M, Parker MJ, McCann MT. Maternal obesity and baseline vitamin D insufficiency alter the response to vitamin D supplementation: a double-blind, randomized trial in pregnant women. Am J Clin Nutr. 2021 Sep 1;114(3):1208-1218. doi: 10.1093/ajcn/nqab112.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
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Recruiting
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Active, not recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pregnancy multi-vitamin (including 10μg vitamin D3) and 10μg vitamin D3 in people with Obesity and Vitamin D Deficiency, run by University of Ulster at 1 site in United Kingdom.

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 9 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 3 Mar 2023. 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 United Kingdom. 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?

Change in Vitamin D (25-hydroxyvitamin D) status (time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + 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 NCT02713009, 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 3 Mar 2023.