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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714361
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
University of Chester

Brief 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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia; Deficiency, Nutritional, With Poor Iron Absorption Vitamin D Deficiency Dietary Supplement: Vitamin D3 supplement Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Double Blind Randomised Controlled Trial to Investigate the Effect of Vitamin D3 Supplementation on Iron Absorption and Hepcidin Response in Marginally Deficient and Iron Deficient Women
Study Start Date : September 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Vitamin D

Arm Intervention/treatment
Active Comparator: Vitamin D3 supplement
Participants will be asked to take 1 capsule of vitamin D3 supplement (1500 IU) (37.5ug) daily for a total duration of 8 weeks.
Dietary Supplement: Vitamin D3 supplement
1500 IU (37.5 mcg) Vitamin D3 capsules daily over 8 weeks (56 days)
Other Name: Cholecalciferol

Placebo Comparator: Placebo
Participants will be asked to take 1 capsule of placebo (65% olive oil) daily for a total duration of 8 weeks.
Other: Placebo
65% olive oil capsules daily over 8 weeks (56 days)
Other Name: Non active ingredient




Primary Outcome Measures :
  1. Change in Ferritin Concentration from Baseline to 8 weeks [ Time Frame: 0 and 8 weeks ]
    Blood biomarker of iron stores measured in plasma samples by Mini Vidas Biomerieux


Secondary Outcome Measures :
  1. Change in Haemoglobin Concentration from Baseline to 8 weeks [ Time Frame: 0,4,8 weeks ]
    Iron status biomarker measured in whole blood by Beckman Coulter haematological analyser

  2. Change in Hepcidin Concentration from Baseline to 8 weeks [ Time Frame: 0,4,8 weeks ]
    Iron metabolism biomarker measured in plasma samples by ELISA commercial kit

  3. Change in Vitamin D Concentration from Baseline to 8 weeks [ Time Frame: 0,4,8 weeks ]
    Vitamin D3 status measured in plasma samples by Mini Vidas Biomerieux

  4. Change in Full Blood Count Concentration from Baseline to 8 weeks [ Time Frame: 0,4,8 weeks ]
    Iron status biomarker measured in whole blood samples by Beckman Coulter haematological analyser

  5. Change in Parathyroid Hormone (PTH) Concentration from Baseline to 8 weeks [ Time Frame: 0,4,8 weeks ]
    Vitamin D metabolism biomarker in plasma samples measured by ELISA commercial kit

  6. Change in Vitamin D Receptor (VDR) Concentration from Baseline to 8 weeks [ Time Frame: 0,4,8 weeks ]
    Vitamin D metabolism biomarker measured in plasma samples by ELISA commercial kit

  7. Change in Calcium Concentration from Baseline to 8 weeks [ Time Frame: 0,4,8 weeks ]
    Vitamin D metabolism biomarker measured in plasma samples by ELISA commercial kit

  8. Change in Calcitriol Concentration from Baseline to 8 weeks [ Time Frame: 0,4,8 weeks ]
    Vitamin D metabolism biomarker measured in plasma samples by ELISA commercial kit

  9. Change in Ferritin Concentration from Baseline to 8 weeks [ Time Frame: 0,4,8 weeks ]
    Iron status biomarker measured in plasma samples by Mini Vidas Biomerieux



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Ages Eligible for Study:   19 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women;
  • aged 19-49 years;
  • healthy;
  • non-pregnant nor lactating;
  • serum ferritin levels less than 20 ug/l and vitamin D concentration below 250 nmol/l.

Exclusion Criteria:

  • history of gastrointestinal and metabolic disorders;
  • have donated blood in the past 6 months;
  • regularly consuming nutritional supplements;
  • haemoglobin levels less than 8.0 g/dL.

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): NCT02714361


Locations
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United Kingdom
University of Chester
Chester, Cheshire, United Kingdom, CH1 4BJ
Sponsors and Collaborators
University of Chester
Medical Research Council
Investigators
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Principal Investigator: Sohail Mushtaq, PhD University of Chester
Publications:
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Responsible Party: University of Chester
ClinicalTrials.gov Identifier: NCT02714361    
Other Study ID Numbers: 1078/15/SF/CSN
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The results are in the writing phase, and will be available in thesis form and possibly publication. It will be available in thesis form in 2017 and publication expected to be in 2018.
Keywords provided by University of Chester:
Iron deficiency
Vitamin D
Iron absorption
Hepcidin
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Vitamin D Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents