Multiple Micronutrient Supplementation vs Iron and Folic Acid Among Pregnant Women in Cambodia

NCT05867836 | Completed

• 1 other identifier: H23-01316
• Study Type: interventional
• Target: 1,545
• Locations: 1 country
• Sites: 1

Brief Summary

Iron and folic acid (IFA) supplements are currently provided to Cambodian women during pregnancy. However, recent research has showed benefit of a multiple micronutrient supplement (MMS) over just IFA alone on several outcomes of perinatal and infant health. The Ministry of Health in Cambodia has proposed a transition from IFA to MMS but would like to collect some formative research on this first to assess acceptability and adherence to MMS (over IFA) and help guide key messaging, packaging, and practices to guide the transition in Cambodia.

Conditions

Pregnancy Related; Antenatal Care; Iron Folic Acid Supplementation

Keywords

Multiple micronutrient supplementation; Adherence; Acceptability

Outcome Measures

Primary Outcomes (1)

• Adherence (counts)

  Adherence as per pill count at the final visit

  90 days for the IFA-90 group and 180 days for the MMS-180 group

Secondary Outcomes (3)

• Adherence (weights)

  90 days for the IFA-90 group and 180 days for the MMS-180 group

• Acceptability (quantitative)

  30 day-, 90 day- and 180-day timepoints

• Acceptability (qualitative)

  90 days for IFA group and 180 days for MMS-180 group

Study Arms (3)

IFA-90

ACTIVE COMPARATOR

Iron and folic acid (IFA) for 90 days

Dietary Supplement: IFA vs. MMS during pregnancy

MMS-90

EXPERIMENTAL

Multiple micronutrient supplementation (MMS) for 90 days with 2 distributions of MMS supplements (2 x 90 pill bottles; distributed at different ANC visits)

Dietary Supplement: IFA vs. MMS during pregnancy

MMS-180

EXPERIMENTAL

Multiple micronutrient supplementation (MMS) for 180 days but with 1 distribution of MMS supplements (1 x 180 pill bottle)

Dietary Supplement: IFA vs. MMS during pregnancy

Interventions

IFA vs. MMS during pregnancy DIETARY_SUPPLEMENT

Iron and folic acid, or multiple micronutrient supplements provided during pregnancy

IFA-90; MMS-180; MMS-90

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant
• Age 18-45 years
• Gestational age less than 14 weeks
• Low risk pregnancy
• Live in Kampong Thom and will not move away within the next 6 months
• Agree to have data collectors come to your home once a month to complete a survey and pill weighing or counting

You may not qualify if:

• Women participating in any nutrition programs beyond the normal care provided though government facilities

Sponsors & Collaborators

• University of British Columbia: lead
• Helen Keller International: collaborator
• Vitamin Angels: collaborator

Study Sites (1)

Kampong Thom province

Kampong Thom, Cambodia

Location

Related Publications (12)

• Clermont A, Kodish SR, Matar Seck A, Salifou A, Rosen J, Grais RF, Isanaka S. Acceptability and Utilization of Three Nutritional Supplements during Pregnancy: Findings from a Longitudinal, Mixed-Methods Study in Niger. Nutrients. 2018 Aug 12;10(8):1073. doi: 10.3390/nu10081073.

  PMID: 30103529 BACKGROUND

• Gonzalez-Casanova I, Nguyen PH, Young MF, Harding KB, Reinhart G, Nguyen H, Nechitillo M, Truong TV, Pham H, Nguyen S, Neufeld LM, Martorell R, Ramakrishnan U. Predictors of adherence to micronutrient supplementation before and during pregnancy in Vietnam. BMC Public Health. 2017 May 16;17(1):452. doi: 10.1186/s12889-017-4379-4.

  PMID: 28511688 BACKGROUND

• Gupta P, Ray M, Dua T, Radhakrishnan G, Kumar R, Sachdev HP. Multimicronutrient supplementation for undernourished pregnant women and the birth size of their offspring: a double-blind, randomized, placebo-controlled trial. Arch Pediatr Adolesc Med. 2007 Jan;161(1):58-64. doi: 10.1001/archpedi.161.1.58.

  PMID: 17199068 BACKGROUND

• Keats EC, Haider BA, Tam E, Bhutta ZA. Multiple-micronutrient supplementation for women during pregnancy. Cochrane Database Syst Rev. 2019 Mar 14;3(3):CD004905. doi: 10.1002/14651858.CD004905.pub6.

  PMID: 30873598 BACKGROUND

• Kulkarni B, Christian P, LeClerq SC, Khatry SK. Determinants of compliance to antenatal micronutrient supplementation and women's perceptions of supplement use in rural Nepal. Public Health Nutr. 2010 Jan;13(1):82-90. doi: 10.1017/S1368980009005862. Epub 2009 May 19.

  PMID: 19454124 BACKGROUND

• Lacerte P, Pradipasen M, Temcharoen P, Imamee N, Vorapongsathorn T. Determinants of adherence to iron/folate supplementation during pregnancy in two provinces in Cambodia. Asia Pac J Public Health. 2011 May;23(3):315-23. doi: 10.1177/1010539511403133.

  PMID: 21593006 BACKGROUND

• Smith ER, Shankar AH, Wu LS, Aboud S, Adu-Afarwuah S, Ali H, Agustina R, Arifeen S, Ashorn P, Bhutta ZA, Christian P, Devakumar D, Dewey KG, Friis H, Gomo E, Gupta P, Kaestel P, Kolsteren P, Lanou H, Maleta K, Mamadoultaibou A, Msamanga G, Osrin D, Persson LA, Ramakrishnan U, Rivera JA, Rizvi A, Sachdev HPS, Urassa W, West KP Jr, Zagre N, Zeng L, Zhu Z, Fawzi WW, Sudfeld CR. Modifiers of the effect of maternal multiple micronutrient supplementation on stillbirth, birth outcomes, and infant mortality: a meta-analysis of individual patient data from 17 randomised trials in low-income and middle-income countries. Lancet Glob Health. 2017 Nov;5(11):e1090-e1100. doi: 10.1016/S2214-109X(17)30371-6.

  PMID: 29025632 BACKGROUND

• Sudfeld CR, Smith ER. New Evidence Should Inform WHO Guidelines on Multiple Micronutrient Supplementation in Pregnancy. J Nutr. 2019 Mar 1;149(3):359-361. doi: 10.1093/jn/nxy279.

  PMID: 30773589 BACKGROUND

• Young SL, Blanco I, Hernandez-Cordero S, Pelto GH, Neufeld LM. Organoleptic properties, ease of use, and perceived health effects are determinants of acceptability of micronutrient supplements among poor Mexican women. J Nutr. 2010 Mar;140(3):605-11. doi: 10.3945/jn.109.113498. Epub 2010 Jan 27.

  PMID: 20107141 BACKGROUND

• West KP Jr, Shamim AA, Mehra S, Labrique AB, Ali H, Shaikh S, Klemm RD, Wu LS, Mitra M, Haque R, Hanif AA, Massie AB, Merrill RD, Schulze KJ, Christian P. Effect of maternal multiple micronutrient vs iron-folic acid supplementation on infant mortality and adverse birth outcomes in rural Bangladesh: the JiVitA-3 randomized trial. JAMA. 2014 Dec 24-31;312(24):2649-58. doi: 10.1001/jama.2014.16819.

  PMID: 25536256 BACKGROUND

• Sauer C, Hoang MA, Kroeun H, Gupta AS, Ngik R, Sokchea M, Labonte JM, Chea M, Klemm R, Mishra A, Panicker A, Sokhal V, Karakochuk CD. Assessing the adherence and acceptability to iron and folic acid compared with multiple micronutrient supplements during pregnancy: a cluster-randomized noninferiority trial in Cambodia. Am J Clin Nutr. 2025 Jul;122(1):166-173. doi: 10.1016/j.ajcnut.2025.04.033. Epub 2025 May 5.

  PMID: 40334750 DERIVED

• Hoang MA, Kroeun H, Klemm R, Gupta AS, Rem N, Meng S, Prak S, Rattana K, Chea M, Karakochuk CD, Sauer C, Mishra A, Mohan D, de-Graffenried MJ. Adherence and acceptability of multiple micronutrient supplementation during pregnancy: Study protocol for a cluster-randomized non-inferiority trial in Cambodia. Trials. 2024 Apr 29;25(1):289. doi: 10.1186/s13063-023-07891-z.

  PMID: 38685109 DERIVED

Study Officials

• Hou Kroeun

  Helen Keller International

  STUDY DIRECTOR

• Crystal D Karakochuk

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Mai A Hoang

  Helen Keller International

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Human Nutrition

Model Details: Clinical trial to assess the adherence and acceptability of iron and folic acid (IFA) vs. multiple micronutrient supplementation (MMS) during pregnancy in Cambodian women

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 22, 2023
• Study Start: March 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)