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Trial record 18 of 2560 for:    vitamin D

Impact of Maternal Body Weight on Vitamin D Status During Pregnancy (MO-VITD)

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ClinicalTrials.gov Identifier: NCT02713009
Recruitment Status : Unknown
Verified March 2016 by University of Ulster.
Recruitment status was:  Recruiting
First Posted : March 18, 2016
Last Update Posted : March 18, 2016
Sponsor:
Collaborator:
Western Health and Social Care Trust
Information provided by (Responsible Party):
University of Ulster

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obesity Vitamin D Deficiency Dietary Supplement: Pregnancy multi-vitamin (including 10μg vitamin D3) Dietary Supplement: 10μg vitamin D3 Dietary Supplement: 0μg vitamin D (placebo) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Investigation of the Impact of Maternal Body Weight on Vitamin D Status During Pregnancy: a Randomised Supplementation Study
Study Start Date : November 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Treatment 1
Pregnancy multivitamin + vitamin D daily from ~Week 12 gestation until delivery
Dietary Supplement: Pregnancy multi-vitamin (including 10μg vitamin D3)
Dietary Supplement: 10μg vitamin D3
Placebo Comparator: Treatment 2
Pregnancy multivitamin + placebo daily from ~Week 12 gestation until delivery
Dietary Supplement: Pregnancy multi-vitamin (including 10μg vitamin D3)
Dietary Supplement: 0μg vitamin D (placebo)



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Gestational weight gain [ Time Frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation) ]
  2. Change in inflammation status [ Time Frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery) ]
    Plasma inflammation status (Week 12, 28 + 36 gestation) & cord plasma inflammation status (delivery)

  3. Change in bone turnover markers [ Time Frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery) ]
    Plasma bone turnover markers (Week 12, 28 + 36 gestation) & cord plasma bone turnover markers (delivery)

  4. Genetics [ Time Frame: Baseline (Week 12 gestation) ]
    e.g. CYP2R1, CYP27B1, CYP24A1

  5. Dietary intake [ Time Frame: Week 28 gestation ]
    Food diary with food frequency questionnaire

  6. Foetal growth chart measurement [ Time Frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery) ]
  7. Change in Vitamin D related measures [ Time Frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery) ]
    Blood Vitamin D related status (Week 12, 28 + 36 gestation) & cord Vitamin D related status (delivery)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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): NCT02713009


Contacts
Contact: Mary T McCann +4428 70 123969 mt.mccann@ulster.ac.uk

Locations
United Kingdom
Western Health and Social Care Trust, Altnagelvin Recruiting
Londonderry, Co.Londonderry, United Kingdom
Contact: Michael Parker, Dr    +442871345171    michael.parker@westerntrust.hscni.net   
Sponsors and Collaborators
University of Ulster
Western Health and Social Care Trust

Responsible Party: University of Ulster
ClinicalTrials.gov Identifier: NCT02713009     History of Changes
Other Study ID Numbers: REC 15/NI/0068
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: March 18, 2016
Last Verified: March 2016

Keywords provided by University of Ulster:
Maternal body weight
Vitamin D
Pregnancy

Additional relevant MeSH terms:
Vitamin D Deficiency
Vitamins
Vitamin D
Body Weight
Signs and Symptoms
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents