Iron DeficiencyNCT02714361
A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women
A study testing Vitamin D3 supplement in people with Iron Deficiency and Anemia; Deficiency, Nutritional, With Poor Iron Absorption, run by University of Chester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency, Anemia; Deficiency, Nutritional, With Poor Iron Absorption, Vitamin D Deficiency
- What is being tested?
- Vitamin D3 supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Recruitment And Sampling Strategy :
Participants will be recruited within the University of Chester, UK only. Emails and posters/leaflets will be used as a medium of advertisement to the target group (staff and students). A total of 62 pre-menopausal women aged between 19 to 40 years old will be included in the study based on criteria described below. Eligibility will be based upon serum ferritin and also vitamin D concentrations at screening before the start of the study. Participants will be required to complete a screening questionnaire which will provide information about participant's health status, drugs/medication/supplement usage, and recent occurrences of illness/trauma/injury. A 6 ml venous blood will be drawn to assess concentrations of plasma ferritin vitamin D, haemoglobin and full blood counts, Participants with plasma ferritin concentrations below 20.0 µg/L and vitamin D concentration below 250 nmol/l will be included in the study. If the levels of haemoglobin are found to be in severe stage of anaemia, the potential participant will be notified and advised to consult their General Practitioner (GP) (haemoglobin levels < 8.0 g/dL). All eligible participants will be briefed on the study protocol before the beginning of the study, and the eligible participants will be given a Participant Information Sheet (PIS) and asked to provide written informed consent.
An 8 week, double blind, randomised controlled trial will be carried out in Chester, United Kingdom (UK). The 8 week intervention period was selected since more than 1 month is appropriate to generally enlarge the erythropoietic marrow and observe changes in red blood cell indices, especially in non-anaemic groups. Most vitamin D studies have used a supplement concentration of 1000 IU and reported no adverse effects in the participants. Some studies have used higher doses of 1600 or 4000 IU with no reported adverse outcomes in the participants.
Participants will be randomly allocated to 2 groups:
- Fe group (iron fortified breakfast cereals and placebo)
- Vitamin D group (iron fortified breakfast cereals and vitamin D3).
Each participant will consume 60 grams of iron fortified breakfast cereals containing a total of 9 mg of iron daily for 8 weeks with either vitamin D3 placebo or vitamin D3 (1500 IU) according to their assigned group. The participants will consume the iron fortified breakfast cereals in the morning, with 200 ml of semi-skimmed milk daily for a period of 8 weeks. The participants will consume the vitamin D or placebo in the evening with 200 ml of water. Participants will be asked to maintain their dietary habits and physical activity during the course of study. Participants will also be asked not to donate blood during the course of the study. The remaining supplements will be returned at the final clinic (week 8), and compliance will be estimated.
Participants will be required to attend 3 clinics in total over a period of 8 weeks, and they will be assessed at baseline (Day 0), interim (Week 4) and post intervention (Week 8). Participants will be requested to fast overnight for approximately 8 hours before all clinics. At each clinic, a 30 ml blood sample will be taken and both height (cm) and weight (kg) will be measured. Before the start and the end of the study, participants will be required to keep a 3-day food diary which includes 2 weekdays and 1 weekend day to represent the habitual dietary intake of the participant. Blood samples will be batch analysed at the end of the intervention to assess all biomarkers of iron status and vitamin D metabolism.
Sample size and justification :
Sample size was estimated using iron supplementation data from a study carried out by Scholz-Ahrens et al. (2004) in which a serum ferritin concentration post intervention at 8 weeks (mean ± S.D) of 17.7 ± 11.8 ug/l (Fe fortified milk group) and 10.6 ± 8.1 ug/l (non fortified milk group) was reported. With an effect size of 0.7015447, the total sample size required for each group in the proposed study is 26. Taking into account a 20% drop out rate, the total sample size required is 31 (Power = 0.80). Therefore, the total sample size needed for the whole study is 62. Sample size was estimated using of G Power Software Version 3.1.7.
Statistical Analysis:
All statistical analyses will be conducted with International Business Machines (IBM) Statistical Package for the Social Sciences (SPSS) Statistic Data Editor Software (Version 21). Assuming that the data is normally distributed after performing a Shapiro Wilks normality test, one-way analysis of variance (ANOVA) with repeated measures will be conducted to compare the mean differences for all measured parameters within each group at baseline, interim and post intervention. The changes in the measured parameters between the periods of the study will be analysed using paired t-test. Pearson's correlation test will be performed to investigate the relationship between hepcidin profile and iron status biomarkers. A non-parametric approach will be adopted if the data is not normally distributed for all analyses. Differences will be considered significant with a p value ≤ 0.05.
- Conditions
- Iron Deficiency, Anemia; Deficiency, Nutritional, With Poor Iron Absorption, Vitamin D Deficiency
- Being tested
- Vitamin D3 supplement, Placebo
- Keywords
- Iron deficiency, Vitamin D, Iron absorption, Hepcidin
- Medical subject headings
- Iron Deficiencies, Anemia, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 supplementDietary supplement
Also called Cholecalciferol
1500 IU (37.5 mcg) Vitamin D3 capsules daily over 8 weeks (56 days)
PlaceboOther
Also called Non active ingredient
65% olive oil capsules daily over 8 weeks (56 days)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ferritin Concentration from Baseline to 8 weeks
Blood biomarker of iron stores measured in plasma samples by Mini Vidas Biomerieux
Measured: 0 and 8 weeks
Secondary outcomes (9)
Change in Haemoglobin Concentration from Baseline to 8 weeks
Iron status biomarker measured in whole blood by Beckman Coulter haematological analyser
Measured: 0,4,8 weeks
Change in Hepcidin Concentration from Baseline to 8 weeks
Iron metabolism biomarker measured in plasma samples by ELISA commercial kit
Measured: 0,4,8 weeks
Change in Vitamin D Concentration from Baseline to 8 weeks
Vitamin D3 status measured in plasma samples by Mini Vidas Biomerieux
Measured: 0,4,8 weeks
Change in Full Blood Count Concentration from Baseline to 8 weeks
Iron status biomarker measured in whole blood samples by Beckman Coulter haematological analyser
Measured: 0,4,8 weeks
Change in Parathyroid Hormone (PTH) Concentration from Baseline to 8 weeks
Vitamin D metabolism biomarker in plasma samples measured by ELISA commercial kit
Measured: 0,4,8 weeks
Change in Vitamin D Receptor (VDR) Concentration from Baseline to 8 weeks
Vitamin D metabolism biomarker measured in plasma samples by ELISA commercial kit
Measured: 0,4,8 weeks
Change in Calcium Concentration from Baseline to 8 weeks
Vitamin D metabolism biomarker measured in plasma samples by ELISA commercial kit
Measured: 0,4,8 weeks
Change in Calcitriol Concentration from Baseline to 8 weeks
Vitamin D metabolism biomarker measured in plasma samples by ELISA commercial kit
Measured: 0,4,8 weeks
Change in Ferritin Concentration from Baseline to 8 weeks
Iron status biomarker measured in plasma samples by Mini Vidas Biomerieux
Measured: 0,4,8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chester
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Sohail Mushtaq, PhD, Principal investigator, University of Chester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714361
- Sponsor's protocol ID
- 1078/15/SF/CSN
- Status last verified
- May 2019
- First submitted
- 13 Nov 2015
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 30819262
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02714361
- Acronym / sponsor ID
- 1078/15/SF/CSN
- Conditions
- Iron Deficiency, Anemia; Deficiency, Nutritional, With Poor Iron Absorption, Vitamin D Deficiency
- Keywords
- Iron deficiency, Vitamin D, Iron absorption, Hepcidin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ChesterUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recruitment And Sampling Strategy :
Participants will be recruited within the University of Chester, UK only. Emails and posters/leaflets will be used as a medium of advertisement to the target group (staff and students). A total of 62 pre-menopausal women aged between 19 to 40 years old will be included in the study based on criteria described below. Eligibility will be based upon serum ferritin and also vitamin D concentrations at screening before the start of the study. Participants will be required to complete a screening questionnaire which will provide information about participant's health status, drugs/medication/supplement usage, and recent occurrences of illness/trauma/injury. A 6 ml venous blood will be drawn to assess concentrations of plasma ferritin vitamin D, haemoglobin and full blood counts, Participants with plasma ferritin concentrations below 20.0 µg/L and vitamin D concentration below 250 nmol/l will be included in the study. If the levels of haemoglobin are found to be in severe stage of anaemia, the potential participant will be notified and advised to consult their General Practitioner (GP) (haemoglobin levels < 8.0 g/dL). All eligible participants will be briefed on the study protocol before the beginning of the study, and the eligible participants will be given a Participant Information Sheet (PIS) and asked to provide written informed consent.
An 8 week, double blind, randomised controlled trial will be carried out in Chester, United Kingdom (UK). The 8 week intervention period was selected since more than 1 month is appropriate to generally enlarge the erythropoietic marrow and observe changes in red blood cell indices, especially in non-anaemic groups. Most vitamin D studies have used a supplement concentration of 1000 IU and reported no adverse effects in the participants. Some studies have used higher doses of 1600 or 4000 IU with no reported adverse outcomes in the participants.
Participants will be randomly allocated to 2 groups:
- Fe group (iron fortified breakfast cereals and placebo)
- Vitamin D group (iron fortified breakfast cereals and vitamin D3).
Each participant will consume 60 grams of iron fortified breakfast cereals containing a total of 9 mg of iron daily for 8 weeks with either vitamin D3 placebo or vitamin D3 (1500 IU) according to their assigned group. The participants will consume the iron fortified breakfast cereals in the morning, with 200 ml of semi-skimmed milk daily for a period of 8 weeks. The participants will consume the vitamin D or placebo in the evening with 200 ml of water. Participants will be asked to maintain their dietary habits and physical activity during the course of study. Participants will also be asked not to donate blood during the course of the study. The remaining supplements will be returned at the final clinic (week 8), and compliance will be estimated.
Participants will be required to attend 3 clinics in total over a period of 8 weeks, and they will be assessed at baseline (Day 0), interim (Week 4) and post intervention (Week 8). Participants will be requested to fast overnight for approximately 8 hours before all clinics. At each clinic, a 30 ml blood sample will be taken and both height (cm) and weight (kg) will be measured. Before the start and the end of the study, participants will be required to keep a 3-day food diary which includes 2 weekdays and 1 weekend day to represent the habitual dietary intake of the participant. Blood samples will be batch analysed at the end of the intervention to assess all biomarkers of iron status and vitamin D metabolism.
Sample size and justification :
Sample size was estimated using iron supplementation data from a study carried out by Scholz-Ahrens et al. (2004) in which a serum ferritin concentration post intervention at 8 weeks (mean ± S.D) of 17.7 ± 11.8 ug/l (Fe fortified milk group) and 10.6 ± 8.1 ug/l (non fortified milk group) was reported. With an effect size of 0.7015447, the total sample size required for each group in the proposed study is 26. Taking into account a 20% drop out rate, the total sample size required is 31 (Power = 0.80). Therefore, the total sample size needed for the whole study is 62. Sample size was estimated using of G Power Software Version 3.1.7.
Statistical Analysis:
All statistical analyses will be conducted with International Business Machines (IBM) Statistical Package for the Social Sciences (SPSS) Statistic Data Editor Software (Version 21). Assuming that the data is normally distributed after performing a Shapiro Wilks normality test, one-way analysis of variance (ANOVA) with repeated measures will be conducted to compare the mean differences for all measured parameters within each group at baseline, interim and post intervention. The changes in the measured parameters between the periods of the study will be analysed using paired t-test. Pearson's correlation test will be performed to investigate the relationship between hepcidin profile and iron status biomarkers. A non-parametric approach will be adopted if the data is not normally distributed for all analyses. Differences will be considered significant with a p value ≤ 0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 supplement | Active comparator | Dietary Supplement: Vitamin D3 supplementParticipants will be asked to take 1 capsule of vitamin D3 supplement (1500 IU) (37.5ug) daily for a total duration of 8 weeks. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be asked to take 1 capsule of placebo (65% olive oil) daily for a total duration of 8 weeks. |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 supplementAlso: Cholecalciferol1500 IU (37.5 mcg) Vitamin D3 capsules daily over 8 weeks (56 days) | Dietary supplement | Vitamin D3 supplement |
| PlaceboAlso: Non active ingredient65% olive oil capsules daily over 8 weeks (56 days) | Other | Placebo |
Primary outcome
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
9 secondary outcomes
Change in Haemoglobin Concentration from Baseline to 8 weeks
Time frame: 0,4,8 weeks
Change in Hepcidin Concentration from Baseline to 8 weeks
Time frame: 0,4,8 weeks
Change in Vitamin D Concentration from Baseline to 8 weeks
Time frame: 0,4,8 weeks
Change in Full Blood Count Concentration from Baseline to 8 weeks
Time frame: 0,4,8 weeks
Change in Parathyroid Hormone (PTH) Concentration from Baseline to 8 weeks
Time frame: 0,4,8 weeks
Change in Vitamin D Receptor (VDR) Concentration from Baseline to 8 weeks
Time frame: 0,4,8 weeks
Change in Calcium Concentration from Baseline to 8 weeks
Time frame: 0,4,8 weeks
Change in Calcitriol Concentration from Baseline to 8 weeks
Time frame: 0,4,8 weeks
Change in Ferritin Concentration from Baseline to 8 weeks
Time frame: 0,4,8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Background: PubMed 30819262Ahmad 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sohail Mushtaq, PhD principal investigator
University of Chester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 supplement in people with Iron Deficiency and Anemia; Deficiency, Nutritional, With Poor Iron Absorption, run by University of Chester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ferritin Concentration from Baseline to 8 weeks (time frame: 0 and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02714361, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.