NCT00197548

A Trial of Micronutrients and Adverse Pregnancy Outcomes

Completed Phase 3 Last updated 9 November 2010

What this trial tests

Phase 3 trial testing Multivitamins-vitamins B-complex, C, and E in Pregnancy in 8,468 participants. Completed in 1 July 2006.

Timeline

1 August 2001

Primary endpoint
1 December 2004

1 July 2006

Quick facts

Lead sponsor	Harvard School of Public Health (HSPH)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	8,468
Start date	1 August 2001
Primary completion	1 December 2004
Estimated completion	1 July 2006

Drugs / interventions tested

• Multivitamins-vitamins B-complex, C, and E
• Placebo

Conditions studied

• Pregnancy — all drugs for Pregnancy →
• Premature Birth — all drugs for Premature Birth →
• Infant, Low Birth Weight — all drugs for Infant, Low Birth Weight →
• Pregnancy Outcomes — all drugs for Pregnancy Outcomes →

Sponsor

Harvard School of Public Health (HSPH)

Who can join

18 and older, female only, with Pregnancy or Premature Birth. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Fetal loss, low birth weight and pre-term birth.
  Time frame: Delivery

Sponsor's own description

The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vitamins and perinatal outcomes among HIV-negative women in Tanzania.
   Fawzi WW, Msamanga GI, Urassa W, Hertzmark E, et al · · 2007 · cited 141× · PMID 17409323 · DOI 10.1056/nejmoa064868
2. Maternal dietary diversity and dietary quality scores in relation to adverse birth outcomes in Tanzanian women.
   Madzorera I, Isanaka S, Wang M, Msamanga GI, et al · · 2020 · cited 57× · PMID 32651998 · DOI 10.1093/ajcn/nqaa172
3. Does early vitamin B₁₂ supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania.
   Winje BA, Kvestad I, Krishnamachari S, Manji K, et al · · 2018 · cited 24× · PMID 29472265 · DOI 10.1136/bmjopen-2017-018962
4. The contribution of preterm birth and intrauterine growth restriction to infant mortality in Tanzania.
   Sania A, Spiegelman D, Rich-Edwards J, Okuma J, et al · · 2014 · cited 23× · PMID 24117986 · DOI 10.1111/ppe.12085
5. The contribution of preterm birth and intrauterine growth restriction to childhood undernutrition in Tanzania.
   Sania A, Spiegelman D, Rich-Edwards J, Hertzmark E, et al · · 2015 · cited 19× · PMID 24720471 · DOI 10.1111/mcn.12123
6. Effect of antenatal and infant micronutrient supplementation on middle childhood and early adolescent development outcomes in Tanzania.
   Sudfeld CR, Manji KP, Darling AM, Kisenge R, et al · · 2019 · cited 11× · PMID 30718805 · DOI 10.1038/s41430-019-0403-3
7. Determinants of anemia in postpartum HIV-negative women in Dar es Salaam, Tanzania.
   Petraro P, Duggan C, Urassa W, Msamanga G, et al · · 2013 · cited 10× · PMID 23612515 · DOI 10.1038/ejcn.2013.71
8. Vitamin B12 is Low in Milk of Early Postpartum Women in Urban Tanzania, and was not Significantly Increased by High dose Supplementation.
   Lweno ON, Sudfeld CR, Hertzmark E, Manji KP, et al · · 2020 · cited 9× · PMID 32244279 · DOI 10.3390/nu12040963