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

NCT02714361 | Completed

• 1 other identifier: 1078/15/SF/CSN
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Iron deficiency; Vitamin D; Iron absorption; Hepcidin

Outcome Measures

Primary Outcomes (1)

• Change in Ferritin Concentration from Baseline to 8 weeks

  Blood biomarker of iron stores measured in plasma samples by Mini Vidas Biomerieux

  0 and 8 weeks

Secondary Outcomes (9)

• Change in Haemoglobin Concentration from Baseline to 8 weeks

  0,4,8 weeks

• Change in Hepcidin Concentration from Baseline to 8 weeks

  0,4,8 weeks

• Change in Vitamin D Concentration from Baseline to 8 weeks

  0,4,8 weeks

• Change in Full Blood Count Concentration from Baseline to 8 weeks

  0,4,8 weeks

• Change in Parathyroid Hormone (PTH) Concentration from Baseline to 8 weeks

  0,4,8 weeks

Study Arms (2)

Vitamin D3 supplement

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Participants will be asked to take 1 capsule of placebo (65% olive oil) daily for a total duration of 8 weeks.

Other: Placebo

Interventions

Vitamin D3 supplement DIETARY_SUPPLEMENT

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

Also known as: Cholecalciferol

Vitamin D3 supplement

Placebo OTHER

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

Also known as: Non active ingredient

Placebo

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chester: lead
• Medical Research Council: collaborator

Study Sites (1)

University of Chester

Chester, Cheshire, CH1 4BJ, United Kingdom

Location

Related Publications (1)

• Ahmad Fuzi SF, Mushtaq S. Vitamin D3 supplementation for 8 weeks leads to improved haematological status following the consumption of an iron-fortified breakfast cereal: a double-blind randomised controlled trial in iron-deficient women. Br J Nutr. 2019 May;121(10):1146-1157. doi: 10.1017/S0007114519000412. Epub 2019 Mar 1.

  PMID: 30819262 BACKGROUND

MeSH Terms

Conditions

Iron Deficiencies; Anemia; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Sohail Mushtaq, PhD

  University of Chester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: March 21, 2016
• Study Start: September 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)