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A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women

NCT02714361 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-05-23

No results posted yet for this study

Summary

Iron is one of the most vital elements in humans as it plays a role in physiological functions such as transferring and storing oxygen, transporting electrons and catalysing numerous reactions, from oxidative metabolism to cellular proliferation. Iron deficiency can be attributed to poor absorption that leads to insufficient iron to meet body requirements. Oral iron supplements have been extensively used to treat iron deficiency and iron deficiency anaemia. However, the use of iron compounds in fortifying foods is one of the best practical approach to combat iron deficiency, while improving diet and food pattern involves long-term goal which can be challenging. Vitamin D has recently been shown to affect hepcidin levels, which in turn has effects on iron status but there are a limited number of studies investigating the hepcidin profile in humans following iron supplementation, and few data are available, especially in humans, despite its role as a primary iron absorption and homeostasis regulator. Although several studies have been carried out using iron fortified products, there is limited data on the potential effect of vitamin D on iron metabolism amongst iron deficient women in particular. Therefore, the present study aims to investigate the effect of vitamin D3 supplementation (1500 IU) consumed with iron fortified breakfast cereals on haematological indicators and hepcidin response in iron deficient women.

Conditions

  • Iron Deficiency
  • Anemia; Deficiency, Nutritional, With Poor Iron Absorption
  • Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

Vitamin D3 supplement

1500 IU (37.5 mcg) Vitamin D3 capsules daily over 8 weeks (56 days)

OTHER

Placebo

65% olive oil capsules daily over 8 weeks (56 days)

Sponsors & Collaborators

Principal Investigators

  • Sohail Mushtaq, PhD · University of Chester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United Kingdom

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02714361 on ClinicalTrials.gov