Perspectives on the design and methodology of periconceptional nutrient supplementation trials

Brabin, Bernard J.; Gies, Sabine; Owens, Stephen; Claeys, Yves; D’Alessandro, Umberto; Tinto, Halidou; Brabin, Loretta

doi:10.1186/s13063-015-1124-0

Trials

Table 8 Supplement compliance and uptake for studies outlined in Fig. 2

From: Perspectives on the design and methodology of periconceptional nutrient supplementation trials

Trial location (reference)	Double blind	Tablet regimen	Supplement duration	Adherence assessment method	Side effects monitored	Adherence
Wales [20]	Yes	Daily	Not reported ^a	Serum folate cut-off	Yes	73 % Not assessed in controls
Gambia [27, 31]	Yes	Daily	Mean 10.9 weeks pre-conception to 11 weeks post-conception	Two weekly home tablet counts	Yes	88 %.
Gambia [27, 31]	Yes	Daily	Median 24.1 weeks	Two weekly home tablet counts	Yes	Supplement clinic attendance 72 %
Hungary [30]	No	Daily	Up to 9 months pre-conception to 3 months gestation	Three monthly tablet counts	Yes	71.5 % full course
						8.9 % no supplements^b
						19.6 % partial supplements^c
Bangladesh [24]	Yes	Daily	Maximum 9 months	Monthly sachet counts	Yes	57.7 ± 26.9 %^d
Bangladesh [24]	Yes	Daily	Mean 72.9 days	Monthly sachet counts	Yes	57.7 ± 26.9 %^d
India [25]	Yes	Daily	≥1 month pre-conception – 3 months post-conception	Three monthly tablet counts	Yes	34 % lost to follow-up before conception
Cuba [36]	No	Daily	One menstrual period before conception − 10 weeks gestation	Not reported	No	19.8 % partial supplements^c
Cuba [36]	No	Daily	One menstrual period before conception − 10 weeks gestation	Not reported	No	55.1 % no supplements^b
Vietnam 1 [33]	No	Weekly vs daily	Up to 9 months	Tablet purchases	No?	50-92.5 %, variable with period of follow-up
Netherlands [37]	No	Daily	Not reported	Self-reported	No?	29.6 % reported not using
China 1 [34]	No	Daily	Maximum 38 months	Monthly bottle counts	No	81–87 % periconceptional^e
						74–75 % late use^f
						68–78 % discontinued^g
China 2 [32, 35]	No	Daily	At least 3 months pre-conception. Mean 149.8 days pre- and 49.3 days post-conception	Monthly capsule counts	No	85.7 % – 93 % compliance
Burkina Faso [21]	Yes	Weekly	Maximum 18 months	Directly observed intake	Yes	Trial in progress
Ireland [22]	Yes	Daily	At least 2 months pre-conception	Tablet counts and blood tests^h	Yes	Not reported
Algeria [38]	No	Single dosage	Either 1–3 months pre-conception, or 1–3 months gestation	Directly observed	Not applicable	100 %ⁱ
Multi-country 1 [23]	Yes	Daily	Continuous until 12^th week gestation	Three monthly capsule counts	Yes	7 % discontinued;^g 3–8 % took 50–79 %; 0.8 % took <50 %
Multi-country 2 [29]	No	Daily	Not reported	Self-reported sachet use	Yes	Trial in progress
Vietnam 2 [26]	Yes	Daily	Maximum 18 months	Two weekly capsule counts	Yes	Trial in progress
Nepal [28]	Yes	Weekly	≤3.5 years	Directly observed	No?	>75 % pregnant ≥ 50 %
Nepal [28]	Yes	Weekly	≤3.5 years	Directly observed	No?	62 % non-pregnant ≥ 50 %

^aFrom time contraception stopped
^bZero adherence
^cIncomplete adherence
^dPercentage total eligible doses consumed
^eStarted supplement before last menstrual period before conception and stopped at end of first trimester
^fStarted supplement during first trimester but after last menstrual period
^gStarted and stopped supplement before last menstrual period before conception
^hCount frequency not reported
ⁱAssuming no refusals

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ISSN: 1745-6215

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