Pregnancy Related Clinical Trial
— MMS-CambodiaOfficial title:
Trial of Adherence and Acceptance of Multiple Micronutrient Supplementation (MMS) vs Iron and Folic Acid (IFA) Among Pregnant Women and Health System Enablers and Constraints Related to MMS in Cambodia
Verified date | May 2024 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 1545 |
Est. completion date | June 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Women participating in any nutrition programs beyond the normal care provided though government facilities |
Country | Name | City | State |
---|---|---|---|
Cambodia | Kampong Thom province | Kampong Thom |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Helen Keller International, Vitamin Angels |
Cambodia,
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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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Adherence (weights) | Adherence as per pill weight (g) at the final visit | 90 days for the IFA-90 group and 180 days for the MMS-180 group | |
Secondary | Acceptability (quantitative) | Acceptability as per survey questionnaire | 30 day-, 90 day- and 180-day timepoints | |
Secondary | Acceptability (qualitative) | Acceptability as per informant interviews | 90 days for IFA group and 180 days for MMS-180 group |
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