Clinical trial NCT04618289: Effect of Vitamin D3-fortified Fruit Juice on Iron Status in Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Keywords: iron status
hepcidin
vitamin D
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 45
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* women of child bearing age
* healthy
* aged 19-40 years
* non-pregnant nor lactating.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Change of plasma ferritin concentration from baseline (week 0) to post intervention (week 8)
timeFrame: 3 time points (Week 0,4,8)
measure: Change of plasma hepcidin concentration from baseline (week 0) to post intervention (week 8)
timeFrame: 3 time points (Week 0,4,8)
measure: Change of full blood counts concentration from baseline (week 0) to post intervention (week 8)
timeFrame: 3 time points (Week 0,4,8)
Secondary outcomes:
measure: Change of plasma 25(OH)D concentration from baseline (week 0) to post intervention (week 8)
timeFrame: 3 time points (Week 0,4,8)
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Universiti Putra Malaysia
state: Selangor
Study officials:
affiliation: Dr
name: Salma Faeza Ahmad Fuzi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahmad 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.