Iron-deficiencyNCT04618289
Effect of Vitamin D3-fortified Fruit Juice on Iron Status in Women
A study testing Vitamin D3-fortified fruit juice supplement in people with Iron-deficiency, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
The present study is designed to utilise vitamin D3 supplements that may potentially act as an iron absorption enhancer to improve iron status in the Malaysian child-bearing aged women with low iron stores. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- Vitamin D3-fortified fruit juice supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteMalaysia
- Study dates
- 14 Aug 2021to 1 Dec 2023
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women of child bearing age
- healthy
- aged 19-40 years
- non-pregnant nor lactating.
Who cannot join
- had a history of gastrointestinal disorder (celiac disease, Crohn's disease, irritable bowel syndrome gastroesophageal reflux disease, peptic ulcers and other related gastrointestinal disorders which may cause nutrient malabsorption) and iron metabolic disorders such as iron overload
- had donated blood since the past 6 months
- regularly consuming nutritional supplements (iron, vitamin D, vitamin C, calcium).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vitamin D3-fortified Fruit Juice Supplementation on the Recovery of Iron Status in Childbearing-aged Women With Marginally Low Iron Stores
The present study is designed to utilise vitamin D3 supplements that may potentially act as an iron absorption enhancer to improve iron status in the Malaysian child-bearing aged women with low iron stores. In addition to investigating the efficacy, this study is also designed to assess the effect of a dose of vitamin D3 (4000 IU) on iron metabolism. The study will include the measurement of plasma hepcidin and 25(OH)D concentrations to investigate a possible mechanism that links vitamin D and iron deficiency, as postulated from the existing literature. For that reason, the aim of the study was to investigate the effect of an 8-week vitamin D3 supplementation on iron status indicators, including hepcidin concentration in childbearing aged Malaysian women with marginal iron stores. It is hypothesised that there will be a significant improvement in haematological indicators following 8-week daily vitamin D3 supplementation in the vitamin D group compared to placebo group. It is also hypothesised that plasma hepcidin concentration will be reduced following 8-week daily vitamin D3 supplementation, which results in increased iron stores.
Read the detailed description
Anaemia is one of the most common micronutrient deficiencies worldwide and 50% of anaemia occurrences were reported to be caused by iron deficiency. The national prevalence of anaemia in Malaysia was 24.6%, which was higher in women (35.5%) compared to men (14.3%). Combatting anaemia/iron deficiency requires cohesive approach, as its occurrence is suggested to be multifactorial. Iron supplements have been widely used, whilst, either dietary pattern modification or iron fortification may be implemented at population levels. Despite numerous approach implemented, the problems are still prevalent. There is recently emerging evidence of the utilisation of vitamin D, as iron absorption enhancer that acts on suppression of hepcidin. However, there is scarcity of randomised controlled trial, investigating the effect of the vitamin D supplementation administered routinely, aiding as an iron absorption enhancer, on iron status especially in the general population, not only in Malaysia but worldwide.
This is a placebo controlled, double-blind randomised controlled trial, designed to investigate the effect of an 8-week vitamin D3-fortified fruit juice supplementation on haematological indicators and hepcidin response in a cohort of marginally-low iron stores Malaysia childbearing-aged women. The study is divided into 2 phases which includes Phase 1 when potential participants will be screened, randomised and Phase 2 where all the eligible participants will consume either vitamin D3-fortified fruit juices containing 4000 IU (100 mcg) (vitamin D) or placebo-fruit juices (placebo) daily for the duration of 8 weeks. At each 4-week interval, 10 ml fasted blood sample will be collected, as well as information on dietary habit and anthropometric measurement. Mixed model repeated measures analysis of variance (ANOVA) will be performed to determine the effect of intervention and the interaction with time points for all iron status and vitamin D status blood biomarkers. The clinical aspects of anticipated findings in the present study may be particularly applied to the recovery of iron status in iron deficient population, through the use of vitamin D supplementation in food fortification as a novel iron absorption enhancer.
- Conditions
- Iron-deficiency
- Being tested
- Vitamin D3-fortified fruit juice supplement
- Keywords
- iron status, hepcidin, vitamin D
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3-fortified fruit juice supplementDietary supplement
Vitamin D3-fortified fruit juice supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Group | Experimental | The vitamin D3-fortified fruit juice supplement that will be used is vitamin D3 cholecalciferol (4000 IU, 100 mcg, Fiatec Biosystem Sdn Bhd, Selangor, Malaysia). Receives: Dietary Supplement: Vitamin D3-fortified fruit juice supplement |
| Placebo Group | Placebo comparator | The matching placebo will be also custom-produced and will be produced in the same manner, without the active ingredients by the same company. The placebo produced will match with vitamin D3 in terms of appearance, size, colour and taste to achieve the double-blind design. Receives: Dietary Supplement: Vitamin D3-fortified fruit juice supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of plasma ferritin concentration from baseline (week 0) to post intervention (week 8)
Iron storage
Measured: 3 time points (Week 0,4,8)
Change of plasma hepcidin concentration from baseline (week 0) to post intervention (week 8)
Iron regulator
Measured: 3 time points (Week 0,4,8)
Change of full blood counts concentration from baseline (week 0) to post intervention (week 8)
Iron status
Measured: 3 time points (Week 0,4,8)
Secondary outcomes (1)
Change of plasma 25(OH)D concentration from baseline (week 0) to post intervention (week 8)
Circulating vitamin D
Measured: 3 time points (Week 0,4,8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start14 Aug 2021
- Primary completion14 Aug 2022
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 120 participants who are eligible to continue with the study will be randomised to receive either 4000 IU (100 mcg) of vitamin D3-fortified fruit juice or placebo-fruit juice. The participants will be instructed to consume the vitamin D3-fortified fruit juice or placebo-fruit juice in the morning by diluting the powder in 150 ml of water, daily, for the 8-week duration of the study. All the participants will be reminded to not alter their dietary habits and physical activity, in addition, to abstaining from donating blood during the course of the study which may interfere with interpretation of study findings.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Salma Faeza Ahmad Fuzi, Universiti Putra Malaysia
- Investigators
- Salma Faeza Ahmad Fuzi, Principal investigator, Dr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618289
- Sponsor's protocol ID
- JKEUPM-2020-033
- Status last verified
- May 2024
- First submitted
- 28 Oct 2020
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suhaimi NA, Loh SP, Ab Manan N, Zalbahar N, Mohamad Alwi MN, Ahmad Fuzi SF. An 8-Week Vitamin D3-Fortified Fruit Drink Supplementation Increases Serum Ferritin Concentration: A Randomized Controlled Trial in Malaysian Women With Low Iron Stores. J Acad Nutr Diet. 2024 Nov;124(11):1440-1450.e1. doi: 10.1016/j.jand.2024.02.013. Epub 2024 Feb 24.
PubMed 38408566Ahmad Fuzi SF, Su Peng L, Zabaha Zalbahar N, Ab Manan N, Mohamad Alwi MN. Effect of vitamin D3-fortified fruit juice supplementation of 4000 IU daily on the recovery of iron status in childbearing-aged women with marginally low iron stores: Protocol for an 8-week, parallel group, double-blind randomized controlled trial. PLoS One. 2022 Mar 25;17(3):e0265772. doi: 10.1371/journal.pone.0265772. eCollection 2022.
PubMed 35333885
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D3-fortified Fruit Juice Supplementation on the Recovery of Iron Status in Childbearing-aged Women With Marginally Low Iron Stores
- ClinicalTrials.gov ID
- NCT04618289
- Acronym / sponsor ID
- JKEUPM-2020-033
- Conditions
- Iron-deficiency
- Keywords
- iron status, hepcidin, vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 14 Aug 2021 (actual)
- Primary completion
- 14 Aug 2022 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 5 Nov 2020 (actual)
- 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.
The present study is designed to utilise vitamin D3 supplements that may potentially act as an iron absorption enhancer to improve iron status in the Malaysian child-bearing aged women with low iron stores. In addition to investigating the efficacy, this study is also designed to assess the effect of a dose of vitamin D3 (4000 IU) on iron metabolism. The study will include the measurement of plasma hepcidin and 25(OH)D concentrations to investigate a possible mechanism that links vitamin D and iron deficiency, as postulated from the existing literature. For that reason, the aim of the study was to investigate the effect of an 8-week vitamin D3 supplementation on iron status indicators, including hepcidin concentration in childbearing aged Malaysian women with marginal iron stores. It is hypothesised that there will be a significant improvement in haematological indicators following 8-week daily vitamin D3 supplementation in the vitamin D group compared to placebo group. It is also hypothesised that plasma hepcidin concentration will be reduced following 8-week daily vitamin D3 supplementation, which results in increased iron stores.
Detailed description
Anaemia is one of the most common micronutrient deficiencies worldwide and 50% of anaemia occurrences were reported to be caused by iron deficiency. The national prevalence of anaemia in Malaysia was 24.6%, which was higher in women (35.5%) compared to men (14.3%). Combatting anaemia/iron deficiency requires cohesive approach, as its occurrence is suggested to be multifactorial. Iron supplements have been widely used, whilst, either dietary pattern modification or iron fortification may be implemented at population levels. Despite numerous approach implemented, the problems are still prevalent. There is recently emerging evidence of the utilisation of vitamin D, as iron absorption enhancer that acts on suppression of hepcidin. However, there is scarcity of randomised controlled trial, investigating the effect of the vitamin D supplementation administered routinely, aiding as an iron absorption enhancer, on iron status especially in the general population, not only in Malaysia but worldwide.
This is a placebo controlled, double-blind randomised controlled trial, designed to investigate the effect of an 8-week vitamin D3-fortified fruit juice supplementation on haematological indicators and hepcidin response in a cohort of marginally-low iron stores Malaysia childbearing-aged women. The study is divided into 2 phases which includes Phase 1 when potential participants will be screened, randomised and Phase 2 where all the eligible participants will consume either vitamin D3-fortified fruit juices containing 4000 IU (100 mcg) (vitamin D) or placebo-fruit juices (placebo) daily for the duration of 8 weeks. At each 4-week interval, 10 ml fasted blood sample will be collected, as well as information on dietary habit and anthropometric measurement. Mixed model repeated measures analysis of variance (ANOVA) will be performed to determine the effect of intervention and the interaction with time points for all iron status and vitamin D status blood biomarkers. The clinical aspects of anticipated findings in the present study may be particularly applied to the recovery of iron status in iron deficient population, through the use of vitamin D supplementation in food fortification as a novel iron absorption enhancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A total of 120 participants who are eligible to continue with the study will be randomised to receive either 4000 IU (100 mcg) of vitamin D3-fortified fruit juice or placebo-fruit juice. The participants will be instructed to consume the vitamin D3-fortified fruit juice or placebo-fruit juice in the morning by diluting the powder in 150 ml of water, daily, for the 8-week duration of the study. All the participants will be reminded to not alter their dietary habits and physical activity, in addition, to abstaining from donating blood during the course of the study which may interfere with interpretation of study findings.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Group | Experimental | Dietary Supplement: Vitamin D3-fortified fruit juice supplementThe vitamin D3-fortified fruit juice supplement that will be used is vitamin D3 cholecalciferol (4000 IU, 100 mcg, Fiatec Biosystem Sdn Bhd, Selangor, Malaysia). |
| Placebo Group | Placebo comparator | Dietary Supplement: Vitamin D3-fortified fruit juice supplementThe matching placebo will be also custom-produced and will be produced in the same manner, without the active ingredients by the same company. The placebo produced will match with vitamin D3 in terms of appearance, size, colour and taste to achieve the double-blind design. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women of child bearing age
- healthy
- aged 19-40 years
- non-pregnant nor lactating.
Key exclusion criteria (3 listed)
- had a history of gastrointestinal disorder (celiac disease, Crohn's disease, irritable bowel syndrome gastroesophageal reflux disease, peptic ulcers and other related gastrointestinal disorders which may cause nutrient malabsorption) and iron metabolic disorders such as iron overload
- had donated blood since the past 6 months
- regularly consuming nutritional supplements (iron, vitamin D, vitamin C, calcium).
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-fortified fruit juice supplementVitamin D3-fortified fruit juice supplement | Dietary supplement | Placebo Group, Vitamin D Group |
Primary outcome
Change of plasma ferritin concentration from baseline (week 0) to post intervention (week 8)
Time frame: 3 time points (Week 0,4,8)
Iron storage
Change of plasma hepcidin concentration from baseline (week 0) to post intervention (week 8)
Time frame: 3 time points (Week 0,4,8)
Iron regulator
Change of full blood counts concentration from baseline (week 0) to post intervention (week 8)
Time frame: 3 time points (Week 0,4,8)
Iron status
1 secondary outcome
Change of plasma 25(OH)D concentration from baseline (week 0) to post intervention (week 8)
Time frame: 3 time points (Week 0,4,8)
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 8 May 2024.
- Derived from this study: PubMed 38408566Suhaimi NA, Loh SP, Ab Manan N, Zalbahar N, Mohamad Alwi MN, Ahmad Fuzi SF. An 8-Week Vitamin D3-Fortified Fruit Drink Supplementation Increases Serum Ferritin Concentration: A Randomized Controlled Trial in Malaysian Women With Low Iron Stores. J Acad Nutr Diet. 2024 Nov;124(11):1440-1450.e1. doi: 10.1016/j.jand.2024.02.013. Epub 2024 Feb 24.
- Derived from this study: PubMed 35333885Ahmad Fuzi SF, Su Peng L, Zabaha Zalbahar N, Ab Manan N, Mohamad Alwi MN. Effect of vitamin D3-fortified fruit juice supplementation of 4000 IU daily on the recovery of iron status in childbearing-aged women with marginally low iron stores: Protocol for an 8-week, parallel group, double-blind randomized controlled trial. PLoS One. 2022 Mar 25;17(3):e0265772. doi: 10.1371/journal.pone.0265772. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Iron-deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
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.
Salma Faeza Ahmad Fuzi principal investigator
Dr
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-fortified fruit juice supplement in people with Iron-deficiency, run by Universiti Putra Malaysia at 1 site in Malaysia.
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 4 inclusion and 3 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 8 May 2024. 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 Malaysia. 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 of plasma ferritin concentration from baseline (week 0) to post intervention (week 8) (time frame: 3 time points (Week 0,4,8)). The study lists 3 primary outcomes in all. 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 NCT04618289, which also lists 2 linked publications.
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 8 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.