Effect of Vitamin D3-fortified Fruit Juice on Iron Status in Women

NCT04618289 | Completed DMC

• 1 other identifier: JKEUPM-2020-033
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron-deficiency

Keywords

iron status; hepcidin; vitamin D

Outcome Measures

Primary Outcomes (3)

• Change of plasma ferritin concentration from baseline (week 0) to post intervention (week 8)

  Iron storage

  3 time points (Week 0,4,8)

• Change of plasma hepcidin concentration from baseline (week 0) to post intervention (week 8)

  Iron regulator

  3 time points (Week 0,4,8)

• Change of full blood counts concentration from baseline (week 0) to post intervention (week 8)

  Iron status

  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)

  3 time points (Week 0,4,8)

Study Arms (2)

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).

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.

Dietary Supplement: Vitamin D3-fortified fruit juice supplement

Interventions

Vitamin D3-fortified fruit juice supplement DIETARY_SUPPLEMENT

Vitamin D3-fortified fruit juice supplement

Placebo Group; Vitamin D Group

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Universiti Putra Malaysia

Serdang, Selangor, 43400, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 35333885 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Salma Faeza Ahmad Fuzi

  Dr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participants and researcher will be double-blinded as to which groups participants will be assigned. The researcher will administer the numbered supplement pot (i.e; 001) to the participants based on the sequence that participants attend their baseline clinic (Week 0). The blinding will be maintained throughout the study period of 8 weeks and allocation will not be unlocked until the end of the data analysis or during any adverse event.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 5, 2020
• Study Start: August 14, 2021
• Primary Completion: August 14, 2022
• Study Completion: December 1, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)