Impact of Maternal Body Weight on Vitamin D Status During Pregnancy
NCT ID: NCT02713009
Last Updated: 2023-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
240 participants
INTERVENTIONAL
2015-11-30
2018-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Vitamin D Status and Metabolism in Human Pregnancy
NCT03051867
Vitamin D and Preeclampsia
NCT01648842
Pregnancy Outcome and Vitamin D Level Among Vitamin D Supplementation During Pregnancy
NCT04591847
Maternal Smoking During Pregnancy and Female Fetal Testosterone Levels
NCT02610751
Strategies to Improve Iodine Status in Early Pregnancy
NCT05170997
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment 1
Pregnancy multivitamin + vitamin D daily from \~Week 12 gestation until delivery
Pregnancy multi-vitamin (including 10μg vitamin D3)
10μg vitamin D3
Treatment 2
Pregnancy multivitamin + placebo daily from \~Week 12 gestation until delivery
Pregnancy multi-vitamin (including 10μg vitamin D3)
0μg vitamin D (placebo)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pregnancy multi-vitamin (including 10μg vitamin D3)
10μg vitamin D3
0μg vitamin D (placebo)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* Participants with a history of NTD affected pregnancies
* Pregnant women with active thyroid disease (e.g., Graves, Hashimoto or thyroiditis)
* Planned home births
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Western Health and Social Care Trust
OTHER
University of Ulster
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Western Health and Social Care Trust, Altnagelvin
Londonderry, Co.Londonderry, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REC 15/NI/0068
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.