Efficacy of Vitamin A Fortified Rice in Lactating Thai Women

NCT03056625 | Unknown

• 1 other identifier: MGR5980155
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Vitamin A deficiency (VAD) remains a public health problem that occurs in children and women. WHO estimates that 190 million preschool age children (under five years of age) and 19.1 million pregnant women have inadequate concentrations of retinol . VAD may increase risk of morbidity and mortality during childhood, pregnancy and postpartum period . In developing countries, vitamin A status in lactating women is not optimal. Even in the United States, vitamin A status of low income pregnant women is marginal. Therefore, women of reproductive age are at risk of vitamin A depletion which compromises the vitamin A status of breastfed infants. Vitamin A is transferred to milk from both retinol binding protein bound and chylomicron associated vitamin A carriers. Because of teratogenicity of vitamin A, the transfer of vitamin A from pregnant mother to the fetus is carefully controlled. This results in all infants born with very low stores of vitamin A . Therefore human milk is still the best vitamin A source for infants. The concentration of vitamin A in breast milk is highest in the first 21 days postpartum (colostrum in the first 4-6 days and transitional milk in the next 7-21 days). Breast milk vitamin A concentrations and an infant's vitamin A status are based on maternal dietary intake. Breast milk retinol concentrations are a useful tool and a unique indicator for lactating women and represents extrapolations of vitamin A status of breastfed infant. In high risk vitamin A deficiency areas, prior recommendation for lactating women was to give two doses of 200,000 IU vitamin A within 6 weeks post-delivery . However, the lack of impact evidence of this regimen led to the WHO's withdrawal of such recommendation as a public health policy . Food-based intervention has been regarded as a sustainable approach to improve population vitamin A status. Most recently, vitamin A-depleted sows fed high-provitamin A carotenoid maize resulted in significant increase in liver stores in nursing piglets and significant higher milk retinol concentrations than sows fed white maize that given a high-dose vitamin A supplement . Previous efforts to fortify staples or common vehicles with vitamin A offer promising solution to prevention of vitamin A deficiency in vulnerable population . Food fortified with vitamin A has potentials to improve women's vitamin A status and to increase the vitamin A concentrations of breast milk . Rice as the most important staple food in Thailand, represents the culture of consumption and lifestyle of Thai people . Recent study in Thai school children fed with extruded rice grains fortified with zinc, iron and vitamin A every weekday for 2 months, significantly increased liver stores of vitamin A, as assessed with a stable isotope technique . Likewise, fortification of rice with vitamin A may also benefit mothers during lactation. The outcomes of this study will be useful to guide the promotion of food-based strategies to improve vitamin A status of mother and infant during lactation.

Conditions

Vitamin A Status

Keywords

fortified rice; lactating women; 13C2-retinol isotope dilution; vitamin A liver store

Outcome Measures

Primary Outcomes (1)

• Vitamin A liver store

  vitamin A concentration per gram liver

  135 days

Secondary Outcomes (2)

• Breast milk retinol

  135 days

• Serum retinol

  121 days

Other Outcomes (2)

• Hb

  135 days

• The gut microbiome

  135 days

Study Arms (2)

Fortified rice

EXPERIMENTAL

Participant will be given vitamin A fortified rice 1 meal/day

Other: Vitamin A fortified rice

Control

PLACEBO COMPARATOR

Participant will be given normal rice 1 meal/day

Other: Normal rice

Interventions

Vitamin A fortified rice OTHER

Lactating women will receive fortified rice one meal per day on weekdays for a period of 14 weeks.

Fortified rice

Normal rice OTHER

Lactating women will receive normal rice one meal per day on weekdays for a period of 14 weeks.

Control

Eligibility Criteria

• Age: 18 Years - 38 Years
• Gender Eligibility Details: lactation women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• free of diseases
• gestational age between 37 to 42 weeks
• willing to breastfeed for a period of 4-6 months

You may not qualify if:

• Hb \> 70 g/L
• Postpartum Hemorrhage
• Twin, Baby with low birth weight
• Receiving vitamin A supplement during the study

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Prince of Songkla University

Pattani, 94000, Thailand

RECRUITING

Related Publications (1)

• Pinkaew S, Udomkesmalee E, Davis CR, Tanumihardjo SA. Vitamin A-fortified rice increases total body vitamin A stores in lactating Thai women measured by retinol isotope dilution: a double-blind, randomized, controlled trial. Am J Clin Nutr. 2021 May 8;113(5):1372-1380. doi: 10.1093/ajcn/nqaa418.

  PMID: 33675342 DERIVED

Study Officials

• Siwaporn Pinkaew, Ph.D

  Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siwaporn Pinkaew, Ph.D

CONTACT

+66899772266; siwaporn.p@psu.ac.th

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: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 17, 2017
• Study Start: March 15, 2017
• Primary Completion: August 31, 2017
• Study Completion: December 24, 2017
• Last Updated: September 20, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)